Abacavir Sulfate and Lamivudine Tablets

Abacavir tablets, in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus (HIV-1) infection. Abacavir tablets, a nucleoside analogue human immunodeficiency virus (HIV-1) reverse transcriptase inhibitor, are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. (1)

• Before initiating abacavir, screen for the HLA-B*5701 allele
• Adults: 600 mg daily, administered as either 300 mg twice daily or 600 mg once daily
• Pediatric Patients Aged 3 Months and Older: Administered either once or twice daily
• Dose should be calculated on body weight (kg) and should not exceed 600 mg daily
• Patients with Hepatic Impairment: Mild hepatic impairment – 200 mg twice daily
• Screening for HLA-B*5701 Allele prior to Starting Abacavir Tablets Screen for the HLA-B*5701 allele prior to initiating therapy with abacavir tablets [see Boxed Warning , Warnings and Precautions ]
• Recommended Dosage for Adult Patients The recommended dosage of abacavir tablets for adults is 600 mg daily, administered orally as either 300 mg twice daily or 600 mg once daily, in combination with other antiretroviral agents
• Recommended Dosage for Pediatric Patients Abacavir tablets are available as scored tablet for HIV-1-infected
• Pediatric patients weighing greater than or equal to 14 kg for whom a solid dosage form is appropriate
• Before prescribing abacavir tablets, children should be assessed for the ability to swallow tablets
• If a child is unable to reliably
• Swallow abacavir tablets, the oral solution formulation should be prescribed
• The recommended oral dosage of abacavir tablets for HIV-1-infected
• Pediatric patients is presented in Table 1

Abacavir tablets, containing abacavir sulfate equivalent to 300 mg abacavir, are yellow colored, biconvex, capsule shaped, coated tablet, debossed with ‘D’ and ‘88’ on either side of the score line on one side and plain with a score line on other side. Tablets: 300 mg scored (3)

• The safety and effectiveness of abacavir have been established
• In pediatric patients aged 3 months and older. Use of abacavir is supported by pharmacokinetic trials and evidence from adequate and well-controlled trials of abacavir
• In adults and pediatric subjects [see Dosage and Administration , Adverse Reactions , Clinical Pharmacology , Clinical Studies ]

Clinical trials of abacavir did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, caution should be exercised in the administration of abacavir in elderly patients reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

• Advise the patient to read the FDA-approved patient labeling (Medication Guide)
• Hypersensitivity Reactions Inform patients: that a Medication Guide and Warning Card summarizing the symptoms of the abacavir hypersensitivity reaction and other product information will be dispensed by the pharmacist with each new prescription and refill of abacavir, and instruct the patient to read the Medication Guide and Warning Card every time to obtain any new information that may be present about abacavir
• The complete text of the Medication Guide is reprinted at the end of this document. to carry the Warning Card with them. …

• Abacavir tablets are contraindicated in patients: who have the HLA-B*5701 allele [see Warnings and Precautions ]. with prior hypersensitivity reaction to abacavir [see Warnings and Precautions ]. with moderate or severe hepatic impairment [see Use in Specific Populations ]
• Presence of HLA-B*5701 allele
• Prior hypersensitivity reaction to abacavir
• Moderate or severe hepatic impairment

Methadone: An increased methadone dose may be required in a small number of patients. (7.1) Riociguat: The riociguat dose may need to be reduced. (7.2) 7.1 Methadone In a trial of 11 HIV-1-infected subjects receiving methadone-maintenance therapy with 600 mg of abacavir twice daily (twice the currently recommended dose), oral methadone clearance increased [see Clinical Pharmacology (12.3) ]. This alteration will not result in a methadone dose modification in the majority of patients; however, an increased methadone dose may be required in a small number of patients. …

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues. (5.2) Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy. (5.3) 5.1 Hypersensitivity Reactions Serious and sometimes fatal hypersensitivity reactions have occurred with abacavir. These hypersensitivity reactions have included multi-organ failure and anaphylaxis and typically occurred within the first 6 weeks of treatment with abacavir (median time to onset was 9 days); although abacavir hypersensitivity reactions have occurred any time during treatment [see Adverse Reactions (6.1) ]. …

The following adverse reactions are discussed in other sections of the labeling: Serious and sometimes fatal hypersensitivity reactions [see Boxed Warning , Warnings and Precautions (5.1) ]. Lactic acidosis and severe hepatomegaly with steatosis [see Warnings and Precautions (5.2) ]. Immune reconstitution syndrome [see Warnings and Precautions (5.3) ]. Myocardial infarction [see Warnings and Precautions (5.4) ]. The most commonly reported adverse reactions of at least moderate intensity (incidence greater than or equal to 10%) in adult HIV-1 clinical trials were nausea, headache, malaise and fatigue, nausea and vomiting, and dreams/sleep disorders. …

8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to abacavir during pregnancy. Healthcare Providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263. …

There is no known specific treatment for overdose with abacavir. If overdose occurs, the patient should be monitored and standard supportive treatment applied as required. It is not known whether abacavir can be removed by peritoneal dialysis or hemodialysis.

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.