www.rxlist.com Open in urlscan Pro
104.18.32.6  Public Scan

Form analysis
0 forms found in the DOM

Text Content

This website uses cookies to deliver its services as described in our Cookie
Policy. By using this website, you agree to the use of cookies.

 * Drugs & Vitamins
   
   * Drugs A-Z
   * Generic Drugs A-Z
   * Drugs by Classification
   * Drugs Comparison (Drug Vs. Drug)
   * Vitamins & Supplements
   * Drug Interaction Checker
   * Pill Identifier
 * Tools & Resources
   
   * Medical Dictionary
   * Slideshows
   * Images
   * Quizzes
     
 * Privacy & Other Trust Info
   
   * Privacy Policy
   * About Us
   * Contact Us
   * Terms of Use
   * Advertising Policy


Search




MYCOBUTIN

 * Generic Name: rifabutin
 * Brand Name: Mycobutin
 * Drug Class: Antitubercular Agents

Medical Editor: John P. Cunha, DO, FACOEP Last updated on RxList: 6/30/2022

home drugs a-z list mycobutin (rifabutin) drug

   
   
 * Related Drugs
   Arikayce Edurant Evotaz
   
   
 * Related Supplements
   Coenzyme Q-10 Glutamine Hydroxymethylbutyrate (Hmb) L-Arginine Lentinan
   Marijuana Saccharomyces Boulardii Same Sangre De Grado Vitamin A Whey Protein
   
   
 * Mycobutin User Reviews


DRUG SUMMARY

WHAT IS MYCOBUTIN?

Mycobutin (rifabutin) is an antibiotic used to prevent mycobacterium avium
complex (MAC) in people with HIV (human immunodeficiency virus) infection.
Mycobutin is also used with other medications to treat tuberculosis in people
with HIV.

WHAT ARE SIDE EFFECTS OF MYCOBUTIN?

Common side effects of Mycobutin include:

 * diarrhea,
 * stomach upset or pain,
 * changes in taste,
 * nausea,
 * vomiting,
 * belching,
 * bloating,
 * loss of appetite,
 * headache,
 * skin rash,
 * itching, or
 * red, orange, or brown discoloration of your skin, tears, sweat, saliva,
   urine, or stools (this side effect is harmless and will disappear when the
   medication is stopped).

Tell your doctor if you have rare but serious side effects of Mycobutin
including:

 * easy bleeding or bruising,
 * signs of a new infection (such as fever, persistent sore throat/cough),
 * muscle weakness or pain,
 * joint pain or swelling,
 * eye pain or redness,
 * vision problems,
 * chest pain or pressure,
 * persistent nausea or vomiting,
 * unusual weakness or tiredness, or
 * yellowing eyes or skin.

Seek medical care or call 911 at once if you have the following serious side
effects:

 * Serious eye symptoms such as sudden vision loss, blurred vision, tunnel
   vision, eye pain or swelling, or seeing halos around lights;
 * Serious heart symptoms such as fast, irregular, or pounding heartbeats;
   fluttering in your chest; shortness of breath; and sudden dizziness,
   lightheartedness, or passing out;
 * Severe headache, confusion, slurred speech, arm or leg weakness, trouble
   walking, loss of coordination, feeling unsteady, very stiff muscles, high
   fever, profuse sweating, or tremors.

This document does not contain all possible side effects and others may occur.
Check with your physician for additional information about side effects.

DOSAGE FOR MYCOBUTIN

It is recommended that Mycobutin Capsules be administered at a dose of 300 mg
once daily.

WHAT DRUGS, SUBSTANCES, OR SUPPLEMENTS INTERACT WITH MYCOBUTIN?

Mycobutin may interact with:

 * other antibiotics, or
 * HIV or AIDS medications

Tell your doctor all prescription and over-the-counter medications and
supplements you use.

MYCOBUTIN DURING PREGNANCY AND BREASTFEEDING

During pregnancy, Mycobutin should be used only when prescribed. It is unknown
if this medication passes into breast milk. Consult your doctor before
breastfeeding. If you have HIV disease, do not breastfeed because breast milk
can transmit HIV.

ADDITIONAL INFORMATION

Our Mycobutin (rifabutin) Side Effects Drug Center provides a comprehensive view
of available drug information on the potential side effects when taking this
medication.


FDA DRUG INFORMATION

 * Drug Description
 * Indications & Dosage
 * Side Effects
 * Drug Interactions
 * Warnings
 * Precautions
 * Overdose & Contraindications
 * Clinical Pharmacology
 * Medication Guide


DESCRIPTION FOR MYCOBUTIN

MYCOBUTIN Capsules for oral administration contain 150 mg of the rifamycin
antimycobacterial agent rifabutin, USP, per capsule, along with the inactive
ingredients microcrystalline cellulose, magnesium stearate, red iron oxide,
silica gel, sodium lauryl sulfate, titanium dioxide, and edible white ink.

The chemical name for rifabutin is
1',4-didehydro-1-deoxy-1,4-dihydro-5'-(2-methylpropyl)-1- oxorifamycin XIV
(Chemical Abstracts Service, 9th Collective Index) or (9S,12E,14S,15R,
16S,17R,18R,19R,20S,21S,22E,
24Z)-6,16,18,20-tetrahydroxy-1'-isobutyl-14-methoxy-
7,9,15,17,19,21,25-heptamethyl-spiro
[9,4-(epoxypentadeca[1,11,13]trienimino)-2Hfuro[ 2',3':7,8]naphth[1,2-d]
imidazole-2,4'-piperidine]-5,10,26-(3H,9H)-trione-16-acetate. Rifabutin has a
molecular formula of C46H62N4O11, a molecular weight of 847.02 and the following
structure:







Rifabutin is a red-violet powder soluble in chloroform and methanol, sparingly
soluble in ethanol, and very slightly soluble in water (0.19 mg/mL). Its log P
value (the base 10 logarithm of the partition coefficient between n-octanol and
water) is 3.2 (n-octanol/water).




USES FOR MYCOBUTIN

MYCOBUTIN Capsules are indicated for the prevention of disseminated
Mycobacterium avium complex (MAC) disease in patients with advanced HIV
infection.


DOSAGE FOR MYCOBUTIN

It is recommended that MYCOBUTIN Capsules be administered at a dose of 300 mg
once daily. For those patients with propensity to nausea, vomiting, or other
gastrointestinal upset, administration of MYCOBUTIN at doses of 150 mg twice
daily taken with food may be useful.

For patients with severe renal impairment (creatinine clearance less than 30
mL/min), consider reducing the dose of MYCOBUTIN by 50%, if toxicity is
suspected. No dosage adjustment is required for patients with mild to moderate
renal impairment. Reduction of the dose of MYCOBUTIN may also be needed for
patients receiving concomitant treatment with certain other drugs (see DRUG
INTERACTIONS).

Mild hepatic impairment does not require a dose modification. The
pharmacokinetics of rifabutin in patients with moderate and severe hepatic
impairment is not known.


HOW SUPPLIED

MYCOBUTIN (rifabutin) Capsules, USP are supplied as hard gelatin capsules having
an opaque red-brown cap and body, imprinted with MYCOBUTIN/PHARMACIA & UPJOHN in
white ink, each containing 150 mg of rifabutin, USP.

MYCOBUTIN is available as follows:

NDC 0013-5301-17 Bottles of 100 capsules

Keep tightly closed and dispense in a tight container as defined in the USP.
Store at 25°C (77°F); excursions permitted to 15°–30°C (59°–86°F) [see USP
Controlled Room Temperature].

Distributed by: Pharmacia & Upjohn Company LLC, A subsidiary of Pfizer Inc. New
York, NY 10017. Revised: Sep 2021


SIDE EFFECTS FOR MYCOBUTIN

ADVERSE REACTIONS FROM CLINICAL TRIALS

MYCOBUTIN Capsules were generally well tolerated in the controlled clinical
trials. Discontinuation of therapy due to an adverse event was required in 16%
of patients receiving MYCOBUTIN, compared to 8% of patients receiving placebo in
these trials. Primary reasons for discontinuation of MYCOBUTIN were rash (4% of
treated patients), gastrointestinal intolerance (3%), and neutropenia (2%).

The following table enumerates adverse experiences that occurred at a frequency
of 1% or greater, among the patients treated with MYCOBUTIN in studies 023 and
027.

Table: 3 Clinical Adverse Experiences Reported in ≥1% of Patients Treated With
MYCOBUTIN

Adverse event MYCOBUTIN
(n = 566) % Placebo
(n = 580) % Body as a whole   Abdominal pain 4 3   Asthenia 1 1   Chest pain 1 1
  Fever 2 1   Headache 3 5   Pain 1 2 Blood and lymphatic system   Leucopenia 10
7   Anemia 1 2 Digestive System   Anorexia 2 2   Diarrhea 3 3   Dyspepsia 3 1
  Eructation 3 1   Flatulence 2 1   Nausea 6 5   Nausea and vomiting 3 2
  Vomiting 1 1 Musculoskeletal system   Myalgia 2 1 Nervous system   Insomnia 1
1 Skin and appendages   Rash 11 8 Special senses   Taste perversion 3 1
Urogenital system   Discolored urine 30 6



CLINICAL ADVERSE EVENTS REPORTED IN <1% OF PATIENTS WHO RECEIVED MYCOBUTIN

Considering data from the 023 and 027 pivotal trials, and from other clinical
studies, MYCOBUTIN appears to be a likely cause of the following adverse events
which occurred in less than 1% of treated patients: flu-like syndrome,
hepatitis, hemolysis, arthralgia, myositis, chest pressure or pain with dyspnea,
skin discoloration, thrombocytopenia, pancytopenia and jaundice.

The following adverse events have occurred in more than one patient receiving
MYCOBUTIN, but an etiologic role has not been established: seizure, paresthesia,
aphasia, confusion, and non-specific T wave changes on electrocardiogram.

When MYCOBUTIN was administered at doses from 1050 mg/day to 2400 mg/day,
generalized arthralgia and uveitis were reported. These adverse experiences
abated when MYCOBUTIN was discontinued.

Mild to severe, reversible uveitis has been reported less frequently when
MYCOBUTIN is used at 300 mg as monotherapy in MAC prophylaxis versus MYCOBUTIN
in combination with clarithromycin for MAC treatment (see also WARNINGS).

Uveitis has been infrequently reported when MYCOBUTIN is used at 300 mg/day as
monotherapy in MAC prophylaxis of HIV-infected persons, even with the
concomitant use of fluconazole and/or macrolide antibacterials. However, if
higher doses of MYCOBUTIN are administered in combination with these agents, the
incidence of uveitis is higher.

Patients who developed uveitis had mild to severe symptoms that resolved after
treatment with corticosteroids and/or mydriatic eye drops; in some severe cases,
however, resolution of symptoms occurred after several weeks.

When uveitis occurs, temporary discontinuance of MYCOBUTIN and ophthalmologic
evaluation are recommended. In most mild cases, MYCOBUTIN may be restarted;
however, if signs or symptoms recur, use of MYCOBUTIN should be discontinued
(Morbidity and Mortality Weekly Report, September 9, 1994).

Corneal deposits have been reported during routine ophthalmologic surveillance
of some HIV-positive pediatric patients receiving MYCOBUTIN as part of a
multiple drug regimen for MAC prophylaxis. The deposits are tiny, almost
transparent, asymptomatic peripheral and central corneal deposits, and do not
impair vision.

The following table enumerates the changes in laboratory values that were
considered as laboratory abnormalities in Studies 023 and 027.

Table 4 Percentage of Patients With Laboratory Abnormalities

Laboratory abnormalities MYCOBUTIN
(n = 566) % PLACEBO
(n = 580) % Chemistry   Increased alkaline phosphatase* <1 3   Increased SGOT† 7
12   Increased SGPT† 9 11 Hematology   Anemia‡ 6 7   Eosinophilia 1 1
  Leukopenia§ 17 16   Neutropenia¶ 25 20   Thrombocytopenia# 5 4 Includes grades
3 or 4 toxicities as specified:
*All values >450 U/L
†All values >150 U/L
‡All hemoglobin values <8.0 g/dL
§All WBC values <1,500/mm3
¶All ANC values <750/mm3
#All platelet count values <50,000/mm3



The incidence of neutropenia in patients treated with MYCOBUTIN was
significantly greater than in patients treated with placebo (p = 0.03). Although
thrombocytopenia was not significantly more common among patients treated with
MYCOBUTIN in these trials, MYCOBUTIN has been clearly linked to thrombocytopenia
in rare cases. One patient in Study 023 developed thrombotic thrombocytopenic
purpura, which was attributed to MYCOBUTIN.

ADVERSE REACTIONS FROM POST-MARKETING EXPERIENCE

Adverse reactions identified through post-marketing surveillance by system organ
class (SOC) are listed below:

Blood and lymphatic system disorders: White blood cell disorders (including
agranulocytosis, lymphopenia, granulocytopenia, neutropenia, white blood cell
count decreased, neutrophil count decreased), platelet count decreased.

Immune system disorders: Hypersensitivity, bronchospasm, rash, and eosinophilia.

Gastrointestinal disorders: Clostridioides difficile colitis/Clostridioides
difficile associated diarrhea.

Pyrexia, rash and other hypersensitivity reactions such as eosinophilia and
bronchospasm might occur, as has been seen with other antibacterials.

A limited occurrence of skin discoloration has been reported.

Severe cutaneous adverse reactions (SCARs)

MYCOBUTIN has been associated with the occurrence of DRESS as well as other
SCARs such as SJS, TEN, and AGEP (see WARNINGS).

Rifamycin hypersensitivity reactions

Hypersensitivity to rifamycins have been reported including flu-like symptoms,
bronchospasm, hypotension, urticaria, angioedema, conjunctivitis,
thrombocytopenia or neutropenia.


DRUG INTERACTIONS FOR MYCOBUTIN

EFFECT OF RIFABUTIN ON THE PHARMACOKINETICS OF OTHER DRUGS

Rifabutin induces CYP3A enzymes and therefore may reduce the plasma
concentrations of drugs metabolized by those enzymes. This effect may reduce the
efficacy of standard doses of such drugs, which include itraconazole,
clarithromycin, and saquinavir.

EFFECT OF OTHER DRUGS ON RIFABUTIN PHARMACOKINETICS

Some drugs that inhibit CYP3A may significantly increase the plasma
concentration of rifabutin. Therefore, carefully monitor for rifabutin
associated adverse events in those patients also receiving CYP3A inhibitors,
which include fluconazole and clarithromycin. In some cases, the dosage of
MYCOBUTIN may need to be reduced when it is coadministered with CYP3A
inhibitors.

Table 2 summarizes the results and magnitude of the pertinent drug interactions
assessed with rifabutin. The clinical relevance of these interactions and
subsequent dose modifications should be judged in light of the population
studied, severity of the disease, patient's drug profile, and the likely impact
on the risk/benefit ratio.

Table 2 Rifabutin Interaction Studies

Coadministered drug Dosing regimen of coadministered drug Dosing regimen of
rifabutin Study population (n) Effect on rifabutin Effect on coadministered drug
Recommendation ANTIRETROVIRALS Amprenavir 1200 mg twice a day for 10 days 300 mg
once a day for 10 days Healthy male subjects (6) ↑ AUC by 193%, ↑ Cmax by 119% ↔
Reduce rifabutin dose by at least 50%. Monitor closely for adverse reactions.
Bictegravir 75 mg once a day 300 mg once a day (fasted) Healthy subjects ND ↓
AUC 38%
↓ Cmin 56%
↓ Cmax 20% Co-administration of rifabutin with Biktarvy
(bictegravir/emtricitabine/tenofovir alafenamide) is not recommended due to an
expected decrease in tenofovir alafenamide in addition to the reported reduction
in bictegravir. Refer to Biktarvy prescribing information for additional
information Delavirdine 400 mg three times a day 300 mg once a day HIV-infected
patients (7) ↑ AUC by 230%,
↑ Cmax by 128% ↓ AUC by 80%,
↓ Cmax by 75%,
↓ Cmin by 17% CONTRAINDICATED Didanosine 167 or 250 mg twice a day for 12 days
300 or 600 mg once a day for 12 days HIV-infected patients (11) ↔ ↔ Doravirine
100 mg single dose 300 mg once a day for 16 days Healthy subjects (12) ND ↓ 50%
in AUC,
↓ 68% in C24
↔ in Cmax If concomitant use is necessary, increase the doravirine dosage as
instructed in doravirine-containing product prescribing information.
Fosamprenavir/ ritonavir 700 mg twice a day plus ritonavir 100 mg twice a day
for 2 weeks 150 mg every other day for 2 weeks Healthy subjects (15) ↔ AUC*
↓ Cmax by 15% ↑ AUC by 35%† ,
↑ Cmax by 36%,
↑ Cmin by 36% Reduce rifabutin dose by at least 75% (to a maximum 150 mg every
other day or three times per week) when given with fosamprenavir/ritonavir
combination. Indinavir 800 mg three times a day for 10 days 300 mg once a day
for 10 days Healthy subjects (10) ↑ AUC by 173%,
↑ Cmax by 134% ↓ AUC by 34%,
↓ Cmax by 25%,
↓ Cmin by 39% Reduce rifabutin dose by 50%, and increase indinavir dose from 800
mg to 1000 mg three times a day. Lopinavir/ ritonavir 400/100 mg twice a day for
20 days 150 mg once a day for 10 days Healthy subjects (14) ↑ AUC by 203%‡
↓ Cmax by 112% ↔ Reduce rifabutin dose by at least 75% (to a maximum 150 mg
every other day or three times per week) when given with lopinavir/ritonavir
combination. Monitor closely for adverse reactions. Reduce rifabutin dosage
further, as needed. Saquinavir/ ritonavir 1000/100 mg twice a day for 14 or 22
days 150 mg every 3 days for 21–22 days Healthy subjects ↑ AUC by 53%§
↑ Cmax by 88%
(n=11) ↓ AUC by 13%,
↓ Cmax by 15%,
(n=19) Reduce rifabutin dose by at least 75% (to a maximum 150 mg every other
day or three times per week) when given with saquinavir/ritonavir combination.
Monitor closely for adverse reactions. Rilpivirine 25 mg once a day 300 mg once
a day Healthy subjects (18) ND ↓ AUC by 42%
↓ Cmin by 48%
↓ Cmax by 31% Co-administration of rifabutin with Odefsey (rilpivirine/tenofovir
alafenamide/emtricitabine) is not recommended, due to an expected decrease in
tenofovir alafenamide in addition to the reported reduction in rilpivirine.
Refer to Odefsey prescribing information for additional information. Ritonavir
500 mg twice a day for 10 days 150 mg once a day for 16 days Healthy subjects
(5) ↑ AUC by 300%,
↑ Cmax by 150% ND Reduce rifabutin dose by at least 75% (to a maximum 150 mg
every other day or three times per week) when given with lopinavir/ritonavir
combination. Monitor closely for adverse reactions. Reduce rifabutin dosage
further, as needed. Tipranavir/ ritonavir 500/200 twice a day for 15 doses 150
mg single dose Healthy subjects (20) ↑ AUC by 190%,
↑ Cmax by 70% ↔ Reduce rifabutin dose by at least 75% (to a maximum 150 mg every
other day or three times per week) when given with tipranavir/ritonavir
combination. Monitor closely for adverse reactions. Reduce rifabutin dosage
further, as needed. Nelfinavir 1250 mg twice a day for 7–8 days 150 mg once a
day for 8 days HIV-infected patients (11) ↑ AUC by 83%¶,
↑ Cmax by 19% ↔ Reduce rifabutin dose by 50% (to 150 mg once a day) and increase
the nelfinavir dose to 1250 mg twice a day. Zidovudine 100 or 200 mg every four
hours 300 or 450 mg once a day HIV-infected patients (16) ↔ ↓ AUC by 32%,
↓ Cmax by 48%, Because zidovudine levels remained within the therapeutic range
during co-administration of rifabutin, dosage adjustments are not necessary.
ANTIFUNGALS Fluconazole 200 mg once a day for 2 weeks 300 mg once a day for 2
weeks HIV-infected patients (12) ↑ AUC by 82%,
↑ Cmax by 88% ↔ Monitor for rifabutin associated adverse events. Reduce
rifabutin dose or suspend MYCOBUTIN use if toxicity is suspected. Posaconazole
200 mg once a day for 10 days 300 mg once a day for 17 days Healthy subjects (8)
↑ AUC by 72%,
↑ Cmax by 31% ↓ AUC by 49%,
↓ Cmax by 43% If co-administration of these two drugs cannot be avoided,
patients should be monitored for adverse events associated with rifabutin
administration, and lack of posaconazole efficacy. Itraconazole 200 mg once a
day 300 mg once a day HIV-Infected patients (6) ↑# ↓ AUC by 70%,
↓ Cmax by 75%, If co-administration of these two drugs cannot be avoided,
patients should be monitored for adverse events associated with rifabutin
administration, and lack of itraconazole efficacy. In a separate study, one case
of uveitis was associated with increased serum rifabutin levels following
coadministration of rifabutin (300 mg once a day) with itraconazole (600–900 mg
once a day). Voriconazole 400 mg twice a day for 7 days (maintenance dose) 300
mg once a day for 7 days Healthy male subjects (12) ↑ AUC by 331%,
↑ Cmax by 195% ↑ AUC by ~100%,
↑ Cmax by ~100%Þ CONTRAINDICATED ANTI-PCP (Pneumocystis carinii pneumonia)
Dapsone 50 mg once a day 300 mg once a day HIV-infected patients (16) ND ↓ AUC
by 27 – 40% Sulfamethoxazole- Trimethoprim 800/160 mg 300 mg once a day
HIV-infected patients (12) ↔ ↓ AUC by 15– 20% ANTI-MAC (Mycobacterium avium
intracellulare complex) Azithromycin 500 mg once a day for 1 day, then 250 mg
once a day for 9 days 300 mg once a day Healthy subjects (6) ↔ ↔ Clarithromycin
500 mg twice a day 300 mg once a day HIV-infected patients (12) ↑ AUC by 75% ↓
AUC by 50% Monitor for rifabutin associated adverse events. Reduce dose or
suspend use of MYCOBUTIN if toxicity is suspected. Alternative treatment for
clarithromycin should be considered when treating patients receiving rifabutin
ANTI-TB (Tuberculosis) Ethambutol 1200 mg 300 mg once a day for 7 days Healthy
subjects (10) ND ↔ Isoniazid 300 mg 300 mg once a day for 7 days Healthy
subjects (6) ND ↔ OTHER Methadone 20 – 100 mg once a day 300 mg once a day for
13 days HIV-infected patients (24) ND ↔ Ethinylestradiol (EE)/Norethindrone (NE)
35 mg EE / 1 mg NE for 21 days 300 mg once a day for 10 days Healthy female
subjects (22) ND EE: ↓ AUC by 35%,
↓ Cmax by 20%
NE: ↓ AUC by 46% Patients should be advised to use additional or alternative
methods of contraception. Theophylline 5 mg/kg 300 mg for 14 days Healthy
subjects (11) ND ↔ indicates increase; ↓ indicates decrease; ↔ indicates no
significant change
ND - No Data
AUC - Area under the Concentration vs. Time Curve; Cmax - Maximum serum
concentration; Cmin – Minimum serum concentration
* compared to rifabutin 300 mg once a day alone
†compared to historical control (fosamprenavir/ritonavir 700/100 mg twice a day)
‡ also taking zidovudine 500 mg once a day
§compared to rifabutin 150 mg once a day alone
¶compared to rifabutin 300 mg once a day alone
#data from a case report
Þcompared to voriconazole 200 mg twice a day alone



OTHER DRUGS

The structurally similar drug, rifampin, is known to reduce the plasma
concentrations of a number of other drugs (see prescribing information for
rifampin). Although a weaker enzyme inducer than rifampin, rifabutin may be
expected to have some effect on those drugs as well.


WARNINGS FOR MYCOBUTIN

TUBERCULOSIS

MYCOBUTIN Capsules must not be administered for MAC prophylaxis to patients with
active tuberculosis. Patients who develop complaints consistent with active
tuberculosis while on prophylaxis with MYCOBUTIN should be evaluated
immediately, so that those with active disease may be given an effective
combination regimen of anti-tuberculosis medications. Administration of
MYCOBUTIN as a single agent to patients with active tuberculosis is likely to
lead to the development of tuberculosis that is resistant both to MYCOBUTIN and
to rifampin.

There is no evidence that MYCOBUTIN is an effective prophylaxis against M.
tuberculosis. Patients requiring prophylaxis against both M. tuberculosis and
Mycobacterium avium complex may be given isoniazid and MYCOBUTIN concurrently.

Tuberculosis in HIV-positive patients is common and may present with atypical or
extrapulmonary findings. Patients are likely to have a nonreactive purified
protein derivative (PPD) despite active disease. In addition to chest X-ray and
sputum culture, the following studies may be useful in the diagnosis of
tuberculosis in the HIV-positive patient: blood culture, urine culture, or
biopsy of a suspicious lymph node.

MAC TREATMENT WITH CLARITHROMYCIN

When MYCOBUTIN is used concomitantly with clarithromycin for MAC treatment, a
decreased dose of MYCOBUTIN is recommended due to the increase in plasma
concentrations of MYCOBUTIN (see DRUG INTERACTIONS, Table 2).

HYPERSENSITIVITY AND RELATED REACTIONS

Hypersensitivity reactions may occur in patients receiving rifamycins. Signs and
symptoms of these reactions may include hypotension, urticaria, angioedema,
acute bronchospasm, conjunctivitis, thrombocytopenia, neutropenia or flu-like
syndrome (weakness, fatigue, muscle pain, nausea, vomiting, headache, fever,
chills, aches, rash, itching, sweats, dizziness, shortness of breath, chest
pain, cough, syncope, palpitations). There have been reports of anaphylaxis with
the use of rifamycins.

Monitor patients receiving MYCOBUTIN therapy for signs and/or symptoms of
hypersensitivity reactions. If these symptoms occur, administer supportive
measures and discontinue MYCOBUTIN.

UVEITIS

Due to the possible occurrence of uveitis, patients should also be carefully
monitored when MYCOBUTIN is given in combination with clarithromycin (or other
macrolides) and/or fluconazole and related compounds (see DRUG INTERACTIONS,
Table 2). If uveitis is suspected, the patient should be referred to an
ophthalmologist and, if considered necessary, treatment with MYCOBUTIN should be
suspended (see also ADVERSE REACTIONS).

CLOSTRIDIOIDES DIFFICILE ASSOCIATED DIARRHEA

Clostridioides difficile associated diarrhea (CDAD) has been reported with use
of nearly all antibacterial agents, including MYCOBUTIN (rifabutin) Capsules,
USP, and may range in severity from mild diarrhea to fatal colitis. Treatment
with antibacterial agents alters the normal flora of the colon leading to
overgrowth of C. difficile.

C. difficile produces toxins A and B which contribute to the development of
CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and
mortality, as these infections can be refractory to antimicrobial therapy and
may require colectomy. CDAD must be considered in all patients who present with
diarrhea following antibacterial use. Careful medical history is necessary since
CDAD has been reported to occur over two months after the administration of
antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibacterial use not directed
against C. difficile may need to be discontinued. Appropriate fluid and
electrolyte management, protein supplementation, antibacterial treatment of C.
difficile, and surgical evaluation should be instituted as clinically indicated.

SEVERE CUTANEOUS ADVERSE REACTIONS

There have been reports of severe cutaneous adverse reactions (SCAR), such as
Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction
with eosinophilia and systemic symptoms (DRESS), and acute generalized
exanthematous pustulosis (AGEP) associated with MYCOBUTIN (see ADVERSE
REACTIONS).

If patients develop a skin rash they should be monitored closely, and MYCOBUTIN
discontinued if lesions progress. Specifically, for DRESS, a multi-system
potential life-threatening SCAR, time to onset of the first symptoms may be
prolonged. DRESS is a clinical diagnosis, and its clinical presentation remains
the basis for decision making. An early withdrawal of MYCOBUTIN is essential
because of the syndrome's mortality and visceral involvement (e.g., liver, bone
marrow or kidney).

ANTIRETROVIRAL DRUG INTERACTIONS

Protease inhibitors act as substrates or inhibitors of CYP3A4 mediated
metabolism. Therefore, due to significant drug-drug interactions between
protease inhibitors and rifabutin, their concomitant use should be based on the
overall assessment of the patient and a patient-specific drug profile. The
concomitant use of protease inhibitors may require at least a 50% reduction in
rifabutin dose, and depending on the protease inhibitor, an adjustment of the
antiretroviral drug dose. Increased monitoring for adverse events is recommended
when using these drug combinations (see DRUG INTERACTIONS).

MYCOBUTIN is a CYP3A inducer. Co-administration with antiretroviral drugs
metabolized by CYP3A, including but not limited to products containing
bictegravir, rilpivirine, or doravirine may decrease plasma concentrations of
those antiretroviral drugs, which may lead to loss of virologic response and
possible development of resistance. Therefore, co-administration with
antiretroviral drugs metabolized by CYP3A is not recommended or there may be a
need to increase the dose of antiretroviral drugs (see DRUG INTERACTIONS).

For further recommendations, please refer to the most recent prescribing
information of the antiretrovirals or contact the specific manufacturer.


PRECAUTIONS FOR MYCOBUTIN

GENERAL

Because treatment with MYCOBUTIN Capsules may be associated with neutropenia,
and more rarely thrombocytopenia, physicians should consider obtaining
hematologic studies periodically in patients receiving prophylaxis with
MYCOBUTIN.

CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY

Long-term carcinogenicity studies were conducted with rifabutin in mice and in
rats. Rifabutin was not carcinogenic in mice at doses up to 180 mg/kg/day, or
approximately 36 times the recommended human daily dose. Rifabutin was not
carcinogenic in the rat at doses up to 60 mg/kg/day, about 12 times the
recommended human dose.

Rifabutin was not mutagenic in the bacterial mutation assay (Ames Test) using
both rifabutin-susceptible and resistant strains. Rifabutin was not mutagenic in
Schizosaccharomyces pombe P1 and was not genotoxic in V-79 Chinese hamster
cells, human lymphocytes in vitro, or mouse bone marrow cells in vivo.

Fertility was impaired in male rats given 160 mg/kg (32 times the recommended
human daily dose).

PREGNANCY

Rifabutin should be used in pregnant women only if the potential benefit
justifies the potential risk to the fetus. There are no adequate and
wellcontrolled studies in pregnant or breastfeeding women.

Reproduction studies have been carried out in rats and rabbits given rifabutin
using dose levels up to 200 mg/kg (about 6 to 13 times the recommended human
daily dose based on body surface area comparisons). No teratogenicity was
observed in either species. In rats, given 200 mg/kg/day, (about 6 times the
recommended human daily dose based on body surface area comparisons), there was
a decrease in fetal viability. In rats, at 40 mg/kg/day (approximately
equivalent to the recommended human daily dose based on body surface area
comparisons), rifabutin caused an increase in fetal skeletal variants. In
rabbits, at 80 mg/kg/day (about 5 times the recommended human daily dose based
on body surface area comparisons), rifabutin caused maternotoxicity and increase
in fetal skeletal anomalies. Because animal reproduction studies are not always
predictive of human response, rifabutin should be used in pregnant women only if
the potential benefit justifies the potential risk to the fetus.

NURSING MOTHERS

It is not known whether rifabutin is excreted in human milk. Because many drugs
are excreted in human milk and because of the potential for serious adverse
reactions in nursing infants, a decision should be made whether to discontinue
nursing or discontinue the drug, taking into account the importance of the drug
to the mother.

PEDIATRIC USE

Safety and effectiveness of rifabutin for prophylaxis of MAC in children have
not been established. Limited safety data are available from treatment use in 22
HIV-positive children with MAC who received MYCOBUTIN in combination with at
least two other antimycobacterials for periods from 1 to 183 weeks. Mean doses
(mg/kg) for these children were: 18.5 (range 15.0 to 25.0) for infants 1 year of
age, 8.6 (range 4.4 to 18.8) for children 2 to 10 years of age, and 4.0 (range
2.8 to 5.4) for adolescents 14 to 16 years of age. There is no evidence that
doses greater than 5 mg/kg daily are useful. Adverse experiences were similar to
those observed in the adult population, and included leukopenia, neutropenia,
and rash. In addition, corneal deposits have been observed in some patients
during routine ophthalmologic surveillance of HIV-positive pediatric patients
receiving MYCOBUTIN as part of a multiple-drug regimen for MAC prophylaxis.
These are tiny, almost transparent, asymptomatic peripheral and central corneal
deposits which do not impair vision. Doses of MYCOBUTIN may be administered
mixed with foods such as applesauce.

GERIATRIC USE

Clinical studies of MYCOBUTIN did not include sufficient numbers of subjects
aged 65 and over to determine whether they respond differently from younger
subjects. Other reported clinical experience has not identified differences in
responses between the elderly and younger patients. In general, dose selection
for an elderly patient should be cautious, usually starting at the low end of
the dosing range, reflecting the greater frequency of decreased hepatic, renal,
or cardiac function, and of concomitant disease or other drug therapy (see
CLINICAL PHARMACOLOGY).


OVERDOSE INFORMATION FOR MYCOBUTIN

No information is available on accidental overdosage in humans.

TREATMENT

While there is no experience in the treatment of overdose with MYCOBUTIN
Capsules, clinical experience with rifamycins suggests that gastric lavage to
evacuate gastric contents (within a few hours of overdose), followed by
instillation of an activated charcoal slurry into the stomach, may help absorb
any remaining drug from the gastrointestinal tract.

Rifabutin is 85% protein bound and distributed extensively into tissues (Vss:8
to 9 L/kg). It is not primarily excreted via the urinary route (less than 10% as
unchanged drug); therefore, neither hemodialysis nor forced diuresis is expected
to enhance the systemic elimination of unchanged rifabutin from the body in a
patient with an overdose of MYCOBUTIN.


CONTRAINDICATIONS FOR MYCOBUTIN

MYCOBUTIN Capsules are contraindicated in patients who have had clinically
significant hypersensitivity to rifabutin or to any other rifamycins.


CLINICAL PHARMACOLOGY FOR MYCOBUTIN

PHARMACOKINETICS

ABSORPTION

Following a single oral dose of 300 mg to nine healthy adult volunteers,
rifabutin was readily absorbed from the gastrointestinal tract with mean (±SD)
peak plasma levels (Cmax) of 375 (±267) ng/mL (range: 141 to 1033 ng/mL)
attained in 3.3 (±0.9) hours (Tmax range: 2 to 4 hours). Absolute
bioavailability assessed in five HIV-positive patients, who received both oral
and intravenous doses, averaged 20%. Total recovery of radioactivity in the
urine indicates that at least 53% of the orally administered rifabutin dose is
absorbed from the gastrointestinal tract. The bioavailability of rifabutin from
the capsule dosage form, relative to an oral solution, was 85% in 12 healthy
adult volunteers. High-fat meals slow the rate without influencing the extent of
absorption from the capsule dosage form. Plasma concentrations post-Cmax
declined in an apparent biphasic manner. Pharmacokinetic dose-proportionality
was established over the 300 mg to 600 mg dose range in nine healthy adult
volunteers (crossover design) and in 16 early symptomatic human immunodeficiency
virus (HIV)-positive patients over a 300 mg to 900 mg dose range.

DISTRIBUTION

Due to its high lipophilicity, rifabutin demonstrates a high propensity for
distribution and intracellular tissue uptake. Following intravenous dosing,
estimates of apparent steady-state distribution volume (9.3 ± 1.5 L/kg) in five
HIV-positive patients exceeded total body water by approximately 15- fold.
Substantially higher intracellular tissue levels than those seen in plasma have
been observed in both rat and man. The lung-to-plasma concentration ratio,
obtained at 12 hours, was approximately 6.5 in four surgical patients who
received an oral dose. Mean rifabutin steady-state trough levels (Cp,minss ;
24-hour post-dose) ranged from 50 to 65 ng/mL in HIV-positive patients and in
healthy adult volunteers. About 85% of the drug is bound in a
concentration-independent manner to plasma proteins over a concentration range
of 0.05 to 1 μg/mL. Binding does not appear to be influenced by renal or hepatic
dysfunction. Rifabutin was slowly eliminated from plasma in seven healthy adult
volunteers, presumably because of distribution-limited elimination, with a mean
terminal half-life of 45 (±17) hours (range: 16 to 69 hours). Although the
systemic levels of rifabutin following multiple dosing decreased by 38%, its
terminal half-life remained unchanged.

METABOLISM

Of the five metabolites that have been identified, 25-O-desacetyl and 31-hydroxy
are the most predominant, and show a plasma metabolite:parent area under the
curve ratio of 0.10 and 0.07, respectively. The former has an activity equal to
the parent drug and contributes up to 10% to the total antimicrobial activity.

EXCRETION

A mass-balance study in three healthy adult volunteers with 14C-labeled
rifabutin showed that 53% of the oral dose was excreted in the urine, primarily
as metabolites. About 30% of the dose is excreted in the feces. Mean systemic
clearance (CLs /F) in healthy adult volunteers following a single oral dose was
0.69 (±0.32) L/hr/kg (range: 0.46 to 1.34 L/hr/kg). Renal and biliary clearance
of unchanged drug each contribute approximately 5% to CLs /F.

PHARMACOKINETICS IN SPECIAL POPULATIONS

GERIATRIC

Compared to healthy volunteers, steady-state kinetics of MYCOBUTIN are more
variable in elderly patients (>70 years).

PEDIATRIC

The pharmacokinetics of MYCOBUTIN have not been studied in subjects under 18
years of age.

RENAL IMPAIRMENT

The disposition of rifabutin (300 mg) was studied in 18 patients with varying
degrees of renal function. Area under plasma concentration time curve (AUC)
increased by about 71% in patients with severe renal impairment (creatinine
clearance below 30 mL/min) compared to patients with creatinine clearance (Crcl)
between 61–74 mL/min. In patients with mild to moderate renal impairment (Crcl
between 30–61 mL/min), the AUC increased by about 41%. In patients with severe
renal impairment, carefully monitor for rifabutin associated adverse events. A
reduction in the dosage of rifabutin is recommended for patients with Crcl <30
mL/min if toxicity is suspected (see DOSAGE AND ADMINISTRATION).

HEPATIC IMPAIRMENT

Mild hepatic impairment does not require a dose modification. The
pharmacokinetics of rifabutin in patients with moderate and severe hepatic
impairment is not known.

MALABSORPTION IN HIV-INFECTED PATIENTS

Alterations in gastric pH due to progressing HIV disease has been linked with
malabsorption of some drugs used in HIV-positive patients (e.g., rifampin,
isoniazid). Drug serum concentrations data from AIDS patients with varying
disease severity (based on CD4+ counts) suggests that rifabutin absorption is
not influenced by progressing HIV disease.

DRUG-DRUG INTERACTIONS

(see also DRUG INTERACTIONS)

Multiple dosing of rifabutin has been associated with induction of hepatic
metabolic enzymes of the CYP3A subfamily. Rifabutin's predominant metabolite
(25-desacetyl rifabutin: LM565), may also contribute to this effect. Metabolic
induction due to rifabutin is likely to produce a decrease in plasma
concentrations of concomitantly administered drugs that are primarily
metabolized by the CYP3A enzymes. Similarly concomitant medications that
competitively inhibit the CYP3A activity may increase plasma concentrations of
rifabutin.

CLINICAL STUDIES

Two randomized, double-blind clinical trials (Study 023 and Study 027) compared
MYCOBUTIN (300 mg/day) to placebo in patients with CDCdefined AIDS and CD4
counts ≤200 cells/μL. These studies accrued patients from 2/90 through 2/92.
Study 023 enrolled 590 patients, with a median CD4 cell count at study entry of
42 cells/μL (mean 61). Study 027 enrolled 556 patients with a median CD4 cell
count at study entry of 40 cells/μL (mean 58).

Endpoints included the following:

 1. MAC bacteremia, defined as at least one blood culture positive for
    Mycobacterium avium complex (MAC) bacteria.
 2. Clinically significant disseminated MAC disease, defined as MAC bacteremia
    accompanied by signs or symptoms of serious MAC infection, including one or
    more of the following: fever, night sweats, rigors, weight loss, worsening
    anemia, and/or elevations in alkaline phosphatase.
 3. Survival.

MAC BACTEREMIA

Participants who received MYCOBUTIN were one-third to one-half as likely to
develop MAC bacteremia as were participants who received placebo. These results
were statistically significant (Study 023: p<0.001; Study 027: p = 0.002).

In Study 023, the one-year cumulative incidence of MAC bacteremia, on an intent
to treat basis, was 9% for patients randomized to MYCOBUTIN and 22% for patients
randomized to placebo. In Study 027, these rates were 13% and 28% for patients
receiving MYCOBUTIN and placebo, respectively.

Most cases of MAC bacteremia (approximately 90% in these studies) occurred among
participants whose CD4 count at study entry was ≤100 cells/ μL. The median and
mean CD4 counts at onset of MAC bacteremia were 13 cells/μL and 24 cells/μL,
respectively. These studies did not investigate the optimal time to begin MAC
prophylaxis.

CLINICALLY SIGNIFICANT DISSEMINATED MAC DISEASE

In association with the decreased incidence of bacteremia, patients on MYCOBUTIN
showed reductions in the signs and symptoms of disseminated MAC disease,
including fever, night sweats, weight loss, fatigue, abdominal pain, anemia, and
hepatic dysfunction.

SURVIVAL

The one-year survival rates in Study 023 were 77% for the group receiving
MYCOBUTIN and 77% for the placebo group. In Study 027, the oneyear survival
rates were 77% for the group receiving MYCOBUTIN and 70% for the placebo group.

These differences were not statistically significant.

MICROBIOLOGY

MECHANISM OF ACTION

Rifabutin inhibits DNA-dependent RNA polymerase in susceptible strains of
Escherichia coli and Bacillus subtilis but not in mammalian cells. In resistant
strains of E. coli, rifabutin, like rifampin, did not inhibit this enzyme. It is
not known whether rifabutin inhibits DNA-dependent RNA polymerase in
Mycobacterium avium or in M. intracellulare which comprise M. avium complex
(MAC).

SUSCEPTIBILITY TESTING

For specific information regarding susceptibility test interpretive criteria and
associated test methods and quality control standards recognized by FDA for this
drug, please see: https://www.fda.gov/STIC.

IN VITRO STUDIES

Rifabutin has demonstrated in vitro activity against M. avium complex (MAC)
organisms isolated from both HIV-positive and HIV-negative people. While-gene
probe techniques may be used to identify these two organisms, many reported
studies did not distinguish between these two species. The vast majority of
isolates from MAC-infected, HIV-positive people are M. avium, whereas in
HIV-negative people, about 40% of the MAC isolates are M. intracellulare.

Various in vitro methodologies employing broth or solid media, with and without
polysorbate 80 (Tween 80), have been used to determine rifabutin MIC values for
mycobacterial species. In general, MIC values determined in broth are several
fold lower than that observed with methods employing solid media. Utilization of
Tween 80 in these assays has been shown to further lower MIC values.

However, MIC values were substantially higher for egg-based compared to
agar-based solid media.

Rifabutin activity against 211 MAC isolates from HIV-positive people was
evaluated in vitro utilizing a radiometric broth and an agar dilution method.
Results showed that 78% and 82% of these isolates had MIC99 values of ≤0.25
μg/mL and ≤1.0 μg/mL, respectively, when evaluated by these two methods.
Rifabutin was also shown to be active against phagocytized, M. avium complex in
a mouse macrophage cell culture model.

Rifabutin has in vitro activity against many strains of Mycobacterium
tuberculosis. In one study, utilizing the radiometric broth method, each of 17
and 20 rifampin-naive clinical isolates tested from the United States and
Taiwan, respectively, were shown to be susceptible to rifabutin concentrations
of ≤0.125 μg/mL.

Cross-resistance between rifampin and rifabutin is commonly observed with M.
tuberculosis and M. avium complex isolates. Isolates of M. tuberculosis
resistant to rifampin are likely to be resistant to rifabutin. Rifampicin and
rifabutin MIC99 values against 523 isolates of M. avium complex were determined
utilizing the agar dilution method (Heifets, Leonid B. and Iseman, Michael D.
Determination of in vitro susceptibility of Mycobacteria to Ansamycin. Am. Rev.
Respir. Dis. 1985; 132(3):710–711).

Table 1 Susceptibility of M. Avium Complex Strains to Rifampin and Rifabutin

% of Strains Susceptible/Resistant to Different Concentrations of Rifabutin
(μg/mL) Susceptibility to Rifampin (μg/mL) Number of Strains Susceptible to 0.5
Resistant to 0.5 only Resistant to 1.0 Resistant to 2.0 Susceptible to 1.0 30
100.0 0.0 0.0 0.0 Resistant to 1.0 only 163 88.3 11.7 0.0 0.0 Resistant to 5.0
105 38.0 57.1 2.9 2.0 Resistant to 10.0 225 20.0 50.2 19.6 10.2 TOTAL 523 49.5
36.7 9.0 4.8



Rifabutin in vitro MIC99 values of ≤0.5 μg/mL, determined by the agar dilution
method, for M. kansasii, M. gordonae and M. marinum have been reported; however,
the clinical significance of these results is unknown.

ANIMAL TOXICOLOGY

Liver abnormalities (increased bilirubin and liver weight) occurred in mice,
rats and monkeys at doses (respectively) 0.5, 1, and 3 times the recommended
human daily dose based on body surface area comparisons. Testicular atrophy
occurred in baboons at doses 2 times the recommended human dose based on body
surface area comparisons, and in rats at doses 6 times the recommended human
daily dose based on body surface area comparisons.


PATIENT INFORMATION FOR MYCOBUTIN

Patients should be advised of the signs and symptoms of both MAC and
tuberculosis, and should be instructed to consult their physicians if they
develop new complaints consistent with either of these diseases. In addition,
since MYCOBUTIN may rarely be associated with myositis and uveitis, patients
should be advised to notify their physicians if they develop signs or symptoms
suggesting either of these disorders.

Urine, feces, saliva, sputum, perspiration, tears, and skin may be colored
brown-orange with rifabutin and some of its metabolites. Soft contact lenses may
be permanently stained. Patients to be treated with MYCOBUTIN should be made
aware of these possibilities.

Diarrhea is a common problem caused by antibacterials which usually ends when
the antibacterial is discontinued. Sometimes, after starting treatment with
antibacterials, patients can develop watery and bloody stools (with or without
stomach cramps and fever) even as late as two or more months after having taken
the last dose of the antibacterial. If this occurs, patients should contact
their physician as soon as possible.


FROM

DRUGS AND TREATMENT RESOURCES

 * What to Know About Ixekizumab
 * Which Type of PrEP Is Right for You?
 * Turning 50? Vaccinations You Need

FEATURED CENTERS

 * What Are the Best PsA Treatments for You?
 * Understanding Biologics
 * 10 Things People With Depression Wish You Knew


REPORT PROBLEMS TO THE FOOD AND DRUG ADMINISTRATION

You are encouraged to report negative side effects of prescription drugs to the
FDA. Visit the website or call 1-800-FDA-1088.FDA MedWatch
Close modal
You are about to visit a website outside of medicinenet. Please familiarize
yourself with this other website's Privacy Policy as it differs from ours.
continue

Pill Identifier Tool Quick, Easy, Pill Identification

Drug Interaction Tool Check Potential Drug Interactions

Pharmacy Locator Tool Including 24 Hour, Pharmacies


 * 
 * 

DRUG CATEGORIES

 * Drugs & Medications
 * Pill Identification Tool
 * Vitamins, Herbs, & Dietary Supplements
 * Dictionary

RXLIST

 * About Us
 * Consumer Contact RxList
 * Terms of Use
 * Privacy Policy
 * Sponsor Policy

Your Privacy Choices

Copyright © 2024 by RxList Inc. An Internet Brands company. RxList does not
provide medical advice, diagnosis or treatment. See additional information.





YOUR CHOICE ON COOKIES

We and our 57 partners store and/or access information on a device, such as
unique IDs in cookies to process personal data. You may accept or manage your
choices by clicking below, including your right to object where legitimate
interest is used, or at any time in the privacy policy page. These choices will
be signaled to our partners and will not affect browsing data.


WE AND OUR PARTNERS PROCESS DATA TO PROVIDE:

Use precise geolocation data. Actively scan device characteristics for
identification. Store and/or access information on a device. Personalised
advertising and content, advertising and content measurement, audience research
and services development. See our List of Partners

Accept Essential Accept All
Customize Choices




ABOUT YOUR PRIVACY

We process your data to deliver content or advertisements and measure the
delivery of such content or advertisements to extract insights about our
website. We share this information with our partners on the basis of consent and
legitimate interest. You may exercise your right to consent or object to a
legitimate interest, based on a specific purpose below or at a partner level in
the link under each purpose. These choices will be signaled to our vendors
participating in the Transparency and Consent Framework.
Allow All


MANAGE CONSENT PREFERENCES

STRICTLY NECESSARY COOKIES

Always Active

These cookies are necessary for the website to function and cannot be switched
off in our systems. They are usually only set in response to actions made by you
which amount to a request for services, such as setting your privacy
preferences, logging in or filling in forms. You can set your browser to block
or alert you about these cookies, but some parts of the site will not then work.
These cookies do not store any personally identifiable information.

TARGETING COOKIES

Targeting Cookies

These cookies may be set through our site by our advertising partners. They may
be used by those companies to build a profile of your interests and show you
relevant adverts on other sites. They do not store directly personal
information, but are based on uniquely identifying your browser and internet
device. If you do not allow these cookies, you will experience less targeted
advertising.

PERFORMANCE COOKIES

Performance Cookies

These cookies allow us to count visits and traffic sources so we can measure and
improve the performance of our site. They help us to know which pages are the
most and least popular and see how visitors move around the site. All
information these cookies collect is aggregated and therefore anonymous. If you
do not allow these cookies we will not know when you have visited our site, and
will not be able to monitor its performance.

FUNCTIONAL COOKIES

Functional Cookies

These cookies enable the website to provide enhanced functionality and
personalisation. They may be set by us or by third party providers whose
services we have added to our pages. If you do not allow these cookies then some
or all of these services may not function properly.

STORE AND/OR ACCESS INFORMATION ON A DEVICE 51 PARTNERS CAN USE THIS PURPOSE

Store and/or access information on a device

Cookies, device or similar online identifiers (e.g. login-based identifiers,
randomly assigned identifiers, network based identifiers) together with other
information (e.g. browser type and information, language, screen size, supported
technologies etc.) can be stored or read on your device to recognise it each
time it connects to an app or to a website, for one or several of the purposes
presented here.

List of IAB Vendors‎ | View Illustrations 

PERSONALISED ADVERTISING AND CONTENT, ADVERTISING AND CONTENT MEASUREMENT,
AUDIENCE RESEARCH AND SERVICES DEVELOPMENT 56 PARTNERS CAN USE THIS PURPOSE

Personalised advertising and content, advertising and content measurement,
audience research and services development

 * USE LIMITED DATA TO SELECT ADVERTISING 46 PARTNERS CAN USE THIS PURPOSE
   
   Switch Label
   
   Advertising presented to you on this service can be based on limited data,
   such as the website or app you are using, your non-precise location, your
   device type or which content you are (or have been) interacting with (for
   example, to limit the number of times an ad is presented to you).
   
   View Illustrations 
   Object to Legitimate Interests Remove Objection

 * CREATE PROFILES FOR PERSONALISED ADVERTISING 39 PARTNERS CAN USE THIS PURPOSE
   
   Switch Label
   
   Information about your activity on this service (such as forms you submit,
   content you look at) can be stored and combined with other information about
   you (for example, information from your previous activity on this service and
   other websites or apps) or similar users. This is then used to build or
   improve a profile about you (that might include possible interests and
   personal aspects). Your profile can be used (also later) to present
   advertising that appears more relevant based on your possible interests by
   this and other entities.
   
   View Illustrations 

 * USE PROFILES TO SELECT PERSONALISED ADVERTISING 39 PARTNERS CAN USE THIS
   PURPOSE
   
   Switch Label
   
   Advertising presented to you on this service can be based on your advertising
   profiles, which can reflect your activity on this service or other websites
   or apps (like the forms you submit, content you look at), possible interests
   and personal aspects.
   
   View Illustrations 

 * CREATE PROFILES TO PERSONALISE CONTENT 13 PARTNERS CAN USE THIS PURPOSE
   
   Switch Label
   
   Information about your activity on this service (for instance, forms you
   submit, non-advertising content you look at) can be stored and combined with
   other information about you (such as your previous activity on this service
   or other websites or apps) or similar users. This is then used to build or
   improve a profile about you (which might for example include possible
   interests and personal aspects). Your profile can be used (also later) to
   present content that appears more relevant based on your possible interests,
   such as by adapting the order in which content is shown to you, so that it is
   even easier for you to find content that matches your interests.
   
   View Illustrations 

 * USE PROFILES TO SELECT PERSONALISED CONTENT 11 PARTNERS CAN USE THIS PURPOSE
   
   Switch Label
   
   Content presented to you on this service can be based on your content
   personalisation profiles, which can reflect your activity on this or other
   services (for instance, the forms you submit, content you look at), possible
   interests and personal aspects. This can for example be used to adapt the
   order in which content is shown to you, so that it is even easier for you to
   find (non-advertising) content that matches your interests.
   
   View Illustrations 

 * MEASURE ADVERTISING PERFORMANCE 52 PARTNERS CAN USE THIS PURPOSE
   
   Switch Label
   
   Information regarding which advertising is presented to you and how you
   interact with it can be used to determine how well an advert has worked for
   you or other users and whether the goals of the advertising were reached. For
   instance, whether you saw an ad, whether you clicked on it, whether it led
   you to buy a product or visit a website, etc. This is very helpful to
   understand the relevance of advertising campaigns.
   
   View Illustrations 
   Object to Legitimate Interests Remove Objection

 * MEASURE CONTENT PERFORMANCE 16 PARTNERS CAN USE THIS PURPOSE
   
   Switch Label
   
   Information regarding which content is presented to you and how you interact
   with it can be used to determine whether the (non-advertising) content e.g.
   reached its intended audience and matched your interests. For instance,
   whether you read an article, watch a video, listen to a podcast or look at a
   product description, how long you spent on this service and the web pages you
   visit etc. This is very helpful to understand the relevance of
   (non-advertising) content that is shown to you.
   
   View Illustrations 
   Object to Legitimate Interests Remove Objection

 * UNDERSTAND AUDIENCES THROUGH STATISTICS OR COMBINATIONS OF DATA FROM
   DIFFERENT SOURCES 33 PARTNERS CAN USE THIS PURPOSE
   
   Switch Label
   
   Reports can be generated based on the combination of data sets (like user
   profiles, statistics, market research, analytics data) regarding your
   interactions and those of other users with advertising or (non-advertising)
   content to identify common characteristics (for instance, to determine which
   target audiences are more receptive to an ad campaign or to certain
   contents).
   
   View Illustrations 
   Object to Legitimate Interests Remove Objection

 * DEVELOP AND IMPROVE SERVICES 48 PARTNERS CAN USE THIS PURPOSE
   
   Switch Label
   
   Information about your activity on this service, such as your interaction
   with ads or content, can be very helpful to improve products and services and
   to build new products and services based on user interactions, the type of
   audience, etc. This specific purpose does not include the development or
   improvement of user profiles and identifiers.
   
   View Illustrations 
   Object to Legitimate Interests Remove Objection

 * USE LIMITED DATA TO SELECT CONTENT 6 PARTNERS CAN USE THIS PURPOSE
   
   Switch Label
   
   Content presented to you on this service can be based on limited data, such
   as the website or app you are using, your non-precise location, your device
   type, or which content you are (or have been) interacting with (for example,
   to limit the number of times a video or an article is presented to you).
   
   View Illustrations 
   Object to Legitimate Interests Remove Objection

List of IAB Vendors‎

USE PRECISE GEOLOCATION DATA 15 PARTNERS CAN USE THIS PURPOSE

Use precise geolocation data

With your acceptance, your precise location (within a radius of less than 500
metres) may be used in support of the purposes explained in this notice.

List of IAB Vendors‎

ACTIVELY SCAN DEVICE CHARACTERISTICS FOR IDENTIFICATION 3 PARTNERS CAN USE THIS
PURPOSE

Actively scan device characteristics for identification

With your acceptance, certain characteristics specific to your device might be
requested and used to distinguish it from other devices (such as the installed
fonts or plugins, the resolution of your screen) in support of the purposes
explained in this notice.

List of IAB Vendors‎

ENSURE SECURITY, PREVENT AND DETECT FRAUD, AND FIX ERRORS 48 PARTNERS CAN USE
THIS PURPOSE

Always Active

Your data can be used to monitor for and prevent unusual and possibly fraudulent
activity (for example, regarding advertising, ad clicks by bots), and ensure
systems and processes work properly and securely. It can also be used to correct
any problems you, the publisher or the advertiser may encounter in the delivery
of content and ads and in your interaction with them.

List of IAB Vendors‎ | View Illustrations 

DELIVER AND PRESENT ADVERTISING AND CONTENT 41 PARTNERS CAN USE THIS PURPOSE

Always Active

Certain information (like an IP address or device capabilities) is used to
ensure the technical compatibility of the content or advertising, and to
facilitate the transmission of the content or ad to your device.

List of IAB Vendors‎ | View Illustrations 

MATCH AND COMBINE DATA FROM OTHER DATA SOURCES 40 PARTNERS CAN USE THIS PURPOSE

Always Active

Information about your activity on this service may be matched and combined with
other information relating to you and originating from various sources (for
instance your activity on a separate online service, your use of a loyalty card
in-store, or your answers to a survey), in support of the purposes explained in
this notice.

List of IAB Vendors‎

LINK DIFFERENT DEVICES 35 PARTNERS CAN USE THIS PURPOSE

Always Active

In support of the purposes explained in this notice, your device might be
considered as likely linked to other devices that belong to you or your
household (for instance because you are logged in to the same service on both
your phone and your computer, or because you may use the same Internet
connection on both devices).

List of IAB Vendors‎

IDENTIFY DEVICES BASED ON INFORMATION TRANSMITTED AUTOMATICALLY 36 PARTNERS CAN
USE THIS PURPOSE

Always Active

Your device might be distinguished from other devices based on information it
automatically sends when accessing the Internet (for instance, the IP address of
your Internet connection or the type of browser you are using) in support of the
purposes exposed in this notice.

List of IAB Vendors‎
Back Button


COOKIE LIST



Search Icon
Filter Icon

Clear
checkbox label label
Apply Cancel
Consent Leg.Interest
checkbox label label
checkbox label label
checkbox label label

Confirm My Choices
Close modal
You are about to visit a website outside of medicinenet. Please familiarize
yourself with this other website's Privacy Policy as it differs from ours.
continue