Mylan receives tentative FDA approval for paediatric formulations of abacavir/lamivudine through innovative collaboration with ViiV Healthcare and Clinton Health Access Initiative - Seite 3

Important Safety Information (ISI) for abacavir and lamivudine tablets 60 mg/30 mg and 120 mg/60 mg for oral suspension

Please consult the full Prescribing Information for labeled safety information for abacavir and lamivudine tablets for oral suspension.

BOXED WARNING: RISK OF HYPERSENSITIVITY REACTIONS, LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY, AND EXACERBATIONS OF HEPATITIS.  See full Prescribing Information for complete boxed warning.

• Serious and sometimes fatal hypersensitivity reactions have been associated with abacavir-containing products.
• Hypersensitivity to abacavir is a multi-organ clinical syndrome.
• Patients who carry the HLA‑B*5701 allele are at high risk for experiencing a hypersensitivity reaction to abacavir.
• Discontinue abacavir and lamivudine as soon as a hypersensitivity reaction is suspected. Regardless of HLA-B*5701 status, permanently discontinue abacavir and lamivudine if hypersensitivity cannot be ruled out, even when other diagnoses are possible.
• Following a hypersensitivity reaction to abacavir, NEVER restart abacavir and lamivudine or any other abacavir‑containing product.
• Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues.
• Severe acute exacerbations of hepatitis B have been reported in patients who are co‑infected with Hepatitis B Virus (HBV) and Human Immunodeficiency Virus (HIV) ‑1 and have discontinued lamivudine. Monitor hepatic function closely in these patients and, if appropriate, initiate anti-hepatitis B treatment.

CONTRAINDICATIONS

• Presence of HLA-B*5701 allele
• Previous hypersensitivity reaction to abacavir or any other component of the product.
• Hepatic impairment.

WARNINGS AND PRECAUTIONS

• Hepatic decompensation, some fatal, has occurred in HIV-1/Hepatitis C Virus (HCV) co‑infected patients receiving combination antiretroviral therapy and interferon alfa with or without ribavirin. Discontinue abacavir and lamivudine as medically appropriate and consider dose reduction or discontinuation of interferon alfa, ribavirin, or both.
• Immune reconstitution syndrome and redistribution/accumulation of body fat have been reported in patients treated with combination antiretroviral therapy.
• Administration of abacavir and lamivudine is not recommended in patients receiving other products containing lamivudine- or zidovudine-containing products or emtricitabine-containing products.
• Pancreatitis: Use with caution in paediatric patients with a history of pancreatitis or other significant risk factors for pancreatitis. Discontinue treatment as clinically appropriate.
• Abacavir and lamivudine tablets 60 mg/30 mg and 120 mg/60 mg for oral suspension contain phenylalanine as part of the artificial sweetener, aspartame. The artificial sweetener may be harmful to people with phenylketonuria.

ADVERSE REACTIONS