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Mycophenolate REMS

Full Prescribing Information

Medication Guide

Important Safety Information

Azurity Pharmaceuticals

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Participant of Mycophenolate REMS




FDA APPROVED.
AVAILABLE SOON.

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See Important Safety Information below.

Click for Full Prescribing Information, including Black Box Warning.

See below for full indication and Important Safety Information.

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IMPORTANT SAFETY INFORMATION


INDICATION

 * MYHIBBINTM (mycophenolate mofetil oral suspension) is an antimetabolite
   immunosuppressant indicated for the prophylaxis of organ rejection in adult
   and pediatric recipients 3 months of age and older of allogeneic kidney,
   heart, or liver transplants, in combination with other immunosuppressants.

WARNING: EMBRYOFETAL TOXICITY, MALIGNANCIES, and SERIOUS INFECTIONS

 * Use during pregnancy is associated with increased risks of first trimester
   pregnancy loss and congenital malformations. Avoid if safer treatment options
   are available. Females of reproductive potential must be counseled regarding
   pregnancy prevention and planning [see Warnings and Precautions (5.1), Use in
   Special Populations (8.1, 8.3)].
 * Increased risk of development of lymphoma and other malignancies,
   particularly of the skin [see Warnings and Precautions (5.2)].
 * Increased susceptibility to bacterial, viral, fungal, and protozoal
   infections, including opportunistic infections and viral reactivation of
   hepatitis B and C, which may lead to hospitalizations and fatal outcomes [see
   Warnings and Precautions (5.3)].

Handling and Disposal: Mycophenolate mofetil (MMF) has demonstrated teratogenic
effects in humans. Wearing disposable gloves is recommended when wiping the
outer surface of the bottle and or the bottle cap. Avoid direct contact of
MYHIBBIN with skin or mucous membranes. Follow applicable special handling and
disposal procedures according to OSHA Hazardous Drugs. Do not use after 60 days
of first opening the bottle.


ADDITIONAL IMPORTANT SAFETY INFORMATION


CONTRAINDICATIONS

Hypersensitivity to mycophenolate mofetil, mycophenolic acid, polysorbate 80, or
any other component of the drug product.


WARNINGS AND PRECAUTIONS

Embryofetal Toxicity

Use of MMF during pregnancy is associated with an increased risk of first
trimester pregnancy loss and an increased risk of congenital malformations,
especially external ear and other facial abnormalities including cleft lip and
palate, and anomalies of the distal limbs, heart, esophagus, kidney, and nervous
system. Females of reproductive potential must be made aware of these risks and
must be counseled regarding pregnancy prevention and planning. Avoid use of
MYHIBBIN during pregnancy if safer treatment options are available.

Lymphoma and Other Malignancies

Patients receiving immunosuppressants, including MYHIBBIN, are at increased risk
of developing lymphomas and other malignancies, particularly of the skin. The
risk appears to be related to the intensity and duration of immunosuppression
rather than to the use of any specific agent. For patients with increased risk
for skin cancer, exposure to sunlight and UV light should be limited by wearing
protective clothing and using a broad-spectrum sunscreen with a high protection
factor.

Post-transplant lymphoproliferative disorder(PTLD) developed in 0.4% to 1% of
patients receiving MMF (2 g or 3 g) with other immunosuppressive agents in
controlled clinical trials of kidney, heart, and liver transplant patients. The
majority of PTLD cases appear to be related to Epstein-Barr Virus (EBV)
infection. The risk of PTLD appears greatest in those individuals who are EBV
seronegative, a population which includes many young children. In pediatric
patients, no other malignancies besides PTLD were observed in clinical trials.

Serious Infections

Patients receiving immunosuppressants, including MYHIBBIN, are at increased risk
of developing bacterial, fungal, protozoal, and new or reactivated viral
infections, including opportunistic infections. The risk increases with the
total immunosuppressive load. These infections may lead to serious
outcomes,including hospitalizations and death.

Consider dose reduction or discontinuation of MYHIBBIN in patients who develop
new infections or reactivate viral infections, weighing the risk that reduced
immunosuppression represents to the functioning allograft.

Blood Dyscrasias: Neutropenia and Pure Red Cell Aplasia (PRCA)

Severe neutropenia [absolute neutrophil count (ANC) <0.5 x 103/µL] developed in
transplant patients receiving MMF 3 g daily. Patients receiving MYHIBBIN should
be monitored for neutropenia. Neutropenia has been observed most frequently in
the period from 31 to 180 days post-transplant in patients treated for
prevention of kidney, heart,and liver rejection. The development of neutropenia
may be related to MYHIBBIN itself, concomitant medications, viral infections, or
a combination of these causes. If neutropenia develops (ANC <1.3 x 103/µL),
dosing with MYHIBBIN should be interrupted or the dose reduced, appropriate
diagnostic tests performed, and the patient managed appropriately.

Consider monitoring with complete blood counts weekly for the first month, twice
monthly for the second and third months, and monthly for the remainder of the
first year.

Gastrointestinal Complications

Gastrointestinal bleeding requiring hospitalization, ulceration, and
perforations were observed in clinical trials. Physicians should be aware of
these serious adverse effects particularly when administering MYHIBBIN to
patients with a gastrointestinal disease.

Patients With Hypoxanthine-Guanine Phosphoribosyltransferase (HGPRT) Deficiency

Mycophenolate mofetil is an inosine monophosphate dehydrogenase (IMPDH)
inhibitor; therefore, it should be avoided in patients with hereditary
deficiencies of HGPRT, such as Lesch-Nyhan and Kelley-Seegmiller syndromes,
because it may cause an exacerbation of disease symptoms characterizedby the
overproduction and accumulation of uric acid leading to symptoms associated with
gout, such as acute arthritis, tophi, nephrolithiasis or urolithiasis, and renal
disease including renal failure.

Acute Inflammatory Syndrome Associated With Mycophenolate Products

Acute inflammatory syndrome (AIS) has been reported with the use of MMF and
mycophenolate products, and some cases have resulted in hospitalization. AIS is
a paradoxical pro-inflammatory reaction characterized by fever, arthralgias,
arthritis, muscle pain, and elevated inflammatory markers, including C-reactive
protein and erythrocyte sedimentation rate, without evidence of infection or
underlying disease recurrence. Symptoms occur within weeks to months of
initiation of treatment or a dose increase. After discontinuation, improvement
of symptoms and inflammatory markers are usually observed within 24 to 48 hours.

Monitor patients for symptoms and laboratory parameters of AIS when starting
treatment with mycophenolate products or when increasing the dosage. Discontinue
treatment and consider other treatment alternatives based on the risk and
benefit for the patient.

Immunizations

During treatment with MYHIBBIN, the use of live attenuated vaccines should be
avoided (e.g., intranasal influenza, measles, mumps, rubella, oral polio, BCG,
yellow fever, varicella, and TY21a typhoid vaccines) and patients should be
advised that vaccinations may be less effective. Advise patients to discuss with
a physician before seeking any immunizations.

Blood Donation

Patients should not donate blood during therapy and for at least 6 weeks
following discontinuation of MYHIBBIN because their blood or blood products
might be administered to a female of reproductive potential or a pregnant woman.

Semen Donation

Based on animal data, men should not donate semen during therapy and for 90 days
following discontinuation of MYHIBBIN

Effect of Concomitant Medications on Mycophenolic Acid Concentrations

A variety of drugs have the potential to alter systemic MPA exposure when
co-administered with MYHIBBIN. Therefore, determination of MPA concentrations in
plasma before and after making any changes to immunosuppressive therapy, or when
adding or discontinuing concomitant medications, may be appropriate to ensure
MPA concentrations remain stable.

Potential Impairment of Ability to Drive or Operate Machinery

MYHIBBIN may impact the ability to drive and use machines. Patients should avoid
driving or using machines if they experience somnolence, confusion, dizziness,
tremors, or hypotension during treatment with MYHIBBIN.


ADVERSE REACTIONS

The most common adverse reactions in clinical trials (≥20%) include diarrhea,
leukopenia, infection, and vomiting, and there is evidence of a higher frequency
of certain types of infections (e.g., opportunistic infection).


DRUG INTERACTIONS

See full prescribing information for drugs that may interfere with systemic
exposure and reduce MYHIBBIN efficacy: antacids with magnesium or aluminum
hydroxide, proton pump inhibitors, drugs that interfere with enterohepatic
recirculation, telmisartan, calcium-free phosphate binders.

MYHIBBIN may reduce the effectiveness of oral contraceptives. Use of additional
barrier contraceptive methods is recommended.

See full prescribing information for other important drug interactions.


USE IN SPECIFIC POPULATIONS

Pregnancy

Use of MMF during pregnancy is associated with an increased risk of first
trimester pregnancy loss and an increased risk of multiple congenital
malformations in multiple organ systems (see Human Data). Oral administration of
mycophenolate to rats and rabbits during the period of organogenesis produced
congenital malformations and pregnancy loss at doses less than the recommended
clinical dose (0.01 to 0.05 times the recommended clinical doses in kidney and
heart transplant patients).

There is a pregnancy exposure registry that monitors pregnancy outcomes in women
exposed to mycophenolate during pregnancy and those becoming pregnant within 6
weeks of discontinuing MYHIBBIN treatment. To report a pregnancy or obtain
information about the registry, visit the Mycophenolate Pregnancy Registry at
www.mycophenolateREMS.com or call 1-800-617-8191.

Females and Males of Reproductive Potential

Females of reproductive potential must be made aware of the increased risk of
first trimester pregnancy loss and congenital malformations and must be
counseled regarding pregnancy prevention and planning.

Pregnancy Planning

For patients who are considering pregnancy, consider alternative
immunosuppressants with less potential for embryofetal toxicity whenever
possible. Risks and benefits of MYHIBBIN should be discussed with the patient.

Pregnancy Testing

To prevent unplanned exposure during pregnancy, all females of reproductive
potential should have a serum or urine pregnancy test with a sensitivity of at
least 25 mlU/mL immediately before starting MYHIBBIN. Another pregnancy test
with the same sensitivity should be done 8 to 10 days later. Repeat pregnancy
tests should be performed during routine follow-up visits. Results of all
pregnancy tests should be discussed with the patient. In the event of a positive
pregnancy test, consider alternative immunosuppressants with less potential for
embryofetal toxicity whenever possible.

Contraception

Female Patients

Females of reproductive potential taking MYHIBBIN must receive contraceptive
counseling and use acceptable contraception. Patients must use acceptable birth
control during the entire MYHIBBIN therapy, and for 6 weeks after stopping
MYHIBBIN, unless the patient chooses abstinence.

Patients should be aware that MYHIBBIN reduces blood levels of the hormones from
the oral contraceptive pill and could theoretically reduce its effectiveness.

Male Patients

Genotoxic effects have been observed in animal studies at exposures exceeding
the human therapeutic exposures by approximately 1.25 times. Thus, the risk of
genotoxic effects on sperm cells cannot be excluded. Based on this potential
risk, sexually active male patients and/or their female partners are recommended
to use effective contraception during treatment of the male patient and for at
least 90 days after cessation of treatment. Also, based on the potential risk of
genotoxic effects, male patients should not donate sperm during treatment with
MYHIBBIN and for at least 90 days after cessation of treatment.

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The Important Safety Information does not include all the information needed to
use MYHIBBIN safely and effectively. Please see the full Prescribing Information
for MYHIBBIN.

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To Report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals, Inc. at
1-800-461-7449, or FDA at 1-800-FDA-1088 or www.fda.gov/MedWatch.

© 2024 Azurity Pharmaceuticals, Inc.

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® 2024 Azurity Pharmaceuticals, Inc. All Rights Reserved. All trademarks
referred to are the property of their respective owners.

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