Abacavir and Lamivudine

ABACAVIR AND LAMIVUDINE- abacavir sulfate and lamivudine tablet, film coated
AvKARE, Inc.

WARNING: HYPERSENSITIVITY REACTIONS, LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS, and EXACERBATIONS OF HEPATITIS B

Hypersensitivity Reactions

Serious and sometimes fatal hypersensitivity reactions, with multiple organ involvement, have occurred with abacavir, a component of abacavir and lamivudine tablets. Patients who carry the HLA-B*5701 allele are at a higher risk of a hypersensitivity reaction to abacavir; although, hypersensitivity reactions have occurred in patients who do not carry the HLA-B*5701 allele [see Warnings and Precautions ( 5.1)] .

Abacavir and lamivudine tablets are contraindicated in patients with a prior hypersensitivity reaction to abacavir and in HLA-B*5701-positive patients [see Contraindications ( 4), Warnings and Precautions ( 5.1)] . All patients should be screened for the HLA-B*5701 allele prior to initiating therapy with abacavir and lamivudine tablets or reinitiation of therapy with abacavir and lamivudine tablets, unless patients have a previously documented HLA-B*5701 allele assessment. Discontinue abacavir and lamivudine tablets immediately if a hypersensitivity reaction is suspected, regardless of HLA-B*5701 status and even when other diagnoses are possible [see Contraindications ( 4), Warnings and Precautions ( 5.1)].

Following a hypersensitivity reaction to abacavir and lamivudine tablets, NEVER restart abacavir and lamivudine tablets or any other abacavir-containing product because more severe symptoms, including death, can occur within hours. Similar severe reactions have also occurred rarely following the reintroduction of abacavir-containing products in patients who have no history of abacavir hypersensitivity [see Warnings and Precautions ( 5.1)].

Lactic Acidosis and Severe Hepatomegaly with Steatosis

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues and other antiretrovirals. Discontinue abacavir and lamivudine tablets if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity occur [see Warnings and Precautions ( 5.2)].

Exacerbations of Hepatitis B

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, which is a component of abacavir and lamivudine tablets. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue abacavir and lamivudine tablets and are co-infected with HIV-1 and HBV. If appropriate, initiation of anti-hepatitis B therapy may be warranted [see Warnings and Precautions ( 5.3)] .

1 INDICATIONS AND USAGE

Abacavir and lamivudine tablets, in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection.

2 DOSAGE AND ADMINISTRATION

2.1 Screening for HLA-B*5701 Allele Prior to Starting Abacavir and Lamivudine Tablets

Screen for the HLA-B*5701 allele prior to initiating therapy with abacavir and lamivudine tablets [see Boxed Warning, Warnings and Precautions ( 5.1)] .

2.2 Recommended Dosage for Adult Patients

The recommended dosage of abacavir and lamivudine tablets for adults is one tablet taken orally once daily, in combination with other antiretroviral agents, with or without food.

2.3 Recommended Dosage for Pediatric Patients

The recommended oral dose of abacavir and lamivudine tablets for pediatric patients weighing at least 25 kg is one tablet daily in combination with other antiretroviral agents [see Clinical Studies ( 14.2)]. Before prescribing abacavir and lamivudine tablets tablets, pediatric patients should be assessed for the ability to swallow tablets.

2.4 Not Recommended Due to Lack of Dosage Adjustment

Because abacavir and lamivudine tablets is a fixed-dose tablet and cannot be dose adjusted, abacavir and lamivudine tablets is not recommended for:

  1. patients with creatinine clearance less than 50 mL per minute [see Use in Specific Populations ( 8.6)].
  2. patients with mild hepatic impairment. Abacavir and lamivudine tablets are contraindicated in patients with moderate or severe hepatic impairment [see Contraindications ( 4), Use in Specific Populations ( 8.7)] .

Use of EPIVIR ® (lamivudine) oral solution or tablets and ZIAGEN ® (abacavir) oral solution may be considered.

3 DOSAGE FORMS AND STRENGTHS

Abacavir and lamivudine tablets USP contain 600 mg of abacavir as abacavir sulfate, USP and 300 mg of lamivudine, USP. The tablets are yellow, film-coated, convex, capsule-shaped tablet debossed with “5382” on one side of the tablet and “TV” on the other side.

4 CONTRAINDICATIONS

Abacavir and lamivudine tablets are contraindicated in patients:Abacavir and lamivudine tablets are contraindicated in patients:

  1. who have the HLA-B*5701 allele [see Warnings and Precautions ( 5.1)]. who have the HLA-B*5701 allele [see Warnings and Precautions ( 5.1)].
  2. with prior hypersensitivity reaction to abacavir [see Warnings and Precautions ( 5.1)] or lamivudine. with prior hypersensitivity reaction to abacavir [see Warnings and Precautions ( 5.1)] or lamivudine.
  3. with moderate or severe hepatic impairment [see Use in Specific Populations ( 8.7)]. with moderate or severe hepatic impairment [see Use in Specific Populations ( 8.7)].

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2020. All Rights Reserved.