MYHIBBIN 200 mg/mL

MYCOPHENOLATE MOFETIL · SUSPENSION · Azurity Pharmaceuticals, Inc.

No Recall History

Plain English

MYHIBBIN is a suspension containing mycophenolate mofetil at 200 mg/mL, taken oral. Manufactured by Azurity Pharmaceuticals, Inc..

Key Facts

Brand Name: MYHIBBIN
Generic Name: MYCOPHENOLATE MOFETIL
NDC Code (Product): 24338-018
Manufacturer: Azurity Pharmaceuticals, Inc.
Strength: 200 mg/mL
Dosage Form: SUSPENSION
Route: ORAL
Marketing Status
Application #: NDA216482
Marketing Start: 06/10/2024

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

off label use15,150 reports

drug ineffective9,825 reports

product use in unapproved indication6,806 reports

diarrhoea4,860 reports

pyrexia4,368 reports

cytomegalovirus infection4,295 reports

pneumonia4,084 reports

condition aggravated3,659 reports

transplant rejection3,488 reports

infection3,232 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE MYHIBBIN is indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney [see Clinical Studies ( 14.1 )], heart [see Clinical Studies ( 14.2 )] or liver transplants [see Clinical Studies ( 14.3 )] , in combination with other immunosuppressants. MYHIBBIN 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. ( 1 )

Dosage & Administration

2 DOSAGE AND ADMINISTRATION ADULTS DOSAGE Kidney Transplant 1 g orally twice daily ( 2.2 ) Heart Transplant 1.5 g orally twice daily ( 2.3 ) Liver Transplant 1.5 g orally twice daily ( 2.4 ) PEDIATRICS Kidney Transplant 600 mg/m 2 orally twice daily, up to maximum of 2 g daily ( 2.2 ) Heart Transplant 600 mg/m 2 orally twice daily (starting dose) up to a maximum of 900 mg/m 2 twice daily (maximum daily dose of 3 g or 15 mL of oral suspension) ( 2.3 ) Liver Transplant 600 mg/m 2 orally twice daily (starting dose) up to a maximum of 900 mg/m 2 twice daily (maximum daily dose of 3 g or 15 mL of oral suspension) ( 2.4 ) Reduce or interrupt dosing in the event of neutropenia. ( 2.5 ) See full prescribing information (FPI) for: dosage modifications for renal impairment and neutropenia ( 2.5 ) 2.1 Important Administration Instructions MYHIBBIN should not be used without the supervision of a physician with experience in immunosuppressive therapy. MYHIBBIN should not be used interchangeably with mycophenolic acid delayed-release tablets without supervision of a physician with experience in immunosuppressive therapy because the rates of absorption following the administration of MYHIBBIN and…

Contraindications

4 CONTRAINDICATIONS MYHIBBIN is contraindicated in patients with a history of hypersensitivity, including anaphylaxis, to mycophenolate mofetil (MMF), mycophenolic acid (MPA), polysorbate 80 (TWEEN) or any other component of the drug product [see Warnings and Precautions ( 5.8 )] . History of hypersensitivity, including anaphylaxis, to mycophenolate mofetil, mycophenolic acid, polysorbate 80 or any component of the drug product ( 4 )

Drug Interactions

7 DRUG INTERACTIONS See FPI 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. ( 7.1 ) MYHIBBIN may reduce effectiveness of oral contraceptives. Use of additional barrier contraceptive methods is recommended. ( 7.2 ) See FPI for other important drug interactions. ( 7 ) 7.1 Effect of Other Drugs on MYHIBBIN Table 3 Drug Interactions with MYHIBBIN that Affect Mycophenolic Acid (MPA) Exposure Antacids with Magnesium or Aluminum Hydroxide Clinical Impact Concomitant use with an antacid containing magnesium or aluminum hydroxide decreases MPA systemic exposure [see Clinical Pharmacology ( 12.3 )] , which may reduce MYHIBBIN efficacy. Prevention or Management Administer magnesium or aluminum hydroxide containing antacids at least 2h after MYHIBBIN. Proton Pump Inhibitors (PPIs) Clinical Impact Concomitant use with PPIs decreases MPA systemic exposure [see Clinical Pharmacology ( 12.3 )] , which may reduce MYHIBBIN efficacy. Prevention or Management Monitor patients for alterations in effic…

Adverse Reactions

6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the label: • Embryofetal Toxicity [see Warnings and Precautions (5.1) ] • Lymphomas and Other Malignancies [see Warnings and Precautions (5.2) ] • Serious Infections [see Warnings and Precautions (5.3) ] • Blood Dyscrasias: Neutropenia, Pure Red Cell Aplasia [see Warnings and Precautions (5.4) ] • Gastrointestinal Complications [see Warnings and Precautions (5.5) ] • Acute Inflammatory Syndrome Associated with Mycophenolate Products [see Warnings and Precautions (5.7) ] • Hypersensitivity Reactions [see Warnings and Precautions (5.8) ] The most common adverse reactions in clinical trials (20 % or greater) include diarrhea, leukopenia, infection, vomiting, and there is evidence of a higher frequency of certain types of infections e.g., opportunistic infection. ( 6.1 ) 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. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug canno…

Frequently Asked Questions

What is MYHIBBIN used for?

MYHIBBIN contains MYCOPHENOLATE MOFETIL. It is a suspension taken oral. Consult your doctor for specific uses.

Is MYHIBBIN a controlled substance?

MYHIBBIN is not classified as a controlled substance by the DEA.

What is the generic name for MYHIBBIN?

The generic name for MYHIBBIN is MYCOPHENOLATE MOFETIL. There are 11 other brand versions of MYCOPHENOLATE MOFETIL.

What is the NDC code for MYHIBBIN 200 mg/mL?

The NDC (National Drug Code) for MYHIBBIN 200 mg/mL is 24338-018, listed by Azurity Pharmaceuticals, Inc..

Product NDC

24338-018

Package NDC

24338-018-01

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