Lamivudine and Zidovudine (Page 6 of 6)

14.2 Prevention of Maternal-Fetal HIV-1 Transmission

The utility of zidovudine alone for the prevention of maternal-fetal HIV-1 transmission was demonstrated in a randomized, double-blind, placebo-controlled trial conducted in HIV-1-infected pregnant women with CD4+ cell counts of 200 to 1,818 cells per mm³ (median in the treated group: 560 cells per mm³) who had little or no previous exposure to zidovudine. Oral zidovudine was initiated between 14 and 34 weeks of gestation (median 11 weeks of therapy) followed by IV administration of zidovudine during labor and delivery. Following birth, neonates received oral zidovudine syrup for 6 weeks. The trial showed a statistically significant difference in the incidence of HIV-1 infection in the neonates (based on viral culture from peripheral blood) between the group receiving zidovudine and the group receiving placebo. Of 363 neonates evaluated in the trial, the estimated risk of HIV-1 infection was 7.8% in the group receiving zidovudine and 24.9% in the placebo group, a relative reduction in transmission risk of 68.7%. Zidovudine was well tolerated by mothers and infants. There was no difference in pregnancy-related adverse events between the treatment groups.

16 HOW SUPPLIED/STORAGE AND HANDLING

Lamivudine and Zidovudine Tablets USP, containing 150 mg lamivudine and 300 mg zidovudine, are white to off-white, modified capsule shaped, biconvex, film-coated tablets with deep breakline in between ‘C’ and ‘60’ on one side and deep breakline on the other side. They are available as follows:

Bottles of 60 NDC 65862-036-60

Cartons of 60 (6 x 10) Unit-dose Tablets NDC 65862-036-10

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

17 PATIENT COUNSELING INFORMATION

Neutropenia and Anemia
Inform patients that the important toxicities associated with zidovudine are neutropenia and/or anemia. Inform them of the extreme importance of having their blood counts followed closely while on therapy, especially for patients with advanced HIV-1 disease [see Boxed Warning, Warnings and Precautions (5.1)].
Myopathy
Inform patients that myopathy and myositis with pathological changes, similar to that produced by HIV-1 disease, have been associated with prolonged use of zidovudine [see Warnings and Precautions (5.2)].
Lactic Acidosis/Hepatomegaly with Steatosis
Advise patients that lactic acidosis and severe hepatomegaly with steatosis have been reported with use of nucleoside analogues and other antiretrovirals. Advise patients to stop taking lamivudine and zidovudine if they develop clinical symptoms suggestive of lactic acidosis or pronounced hepatotoxicity [see Warnings and Precautions (5.3)].
Patients with Hepatitis B or C Co-infection
Advise patients co-infected with HIV-1 and HBV that worsening of liver disease has occurred in some cases when treatment with lamivudine was discontinued. Advise patients to discuss any changes in regimen with their healthcare provider [see Warnings and Precautions (5.4)].
Inform patients with HIV-1/HCV co-infection that hepatic decompensation (some fatal) has occurred in HIV-1/HCV co-infected patients receiving combination antiretroviral therapy for HIV-1 and interferon alfa with or without ribavirin [see Warnings and Precautions (5.5)].
Drug Interactions
Advise patients that other medications may interact with lamivudine and zidovudine and certain medications, including ganciclovir, interferon alfa, and ribavirin, may exacerbate the toxicity of zidovudine, a component of lamivudine and zidovudine [see Drug Interactions (7.1)].
Immune Reconstitution Syndrome

Advise patients to inform their healthcare provider immediately of any signs and symptoms of infection as inflammation from previous infection may occur soon after combination antiretroviral therapy, including when lamivudine and zidovudine is started [see Warnings and Precautions (5.7)].

Lipoatrophy

Advise patients that loss of subcutaneous fat may occur in patients receiving lamivudine and zidovudine and that they will be regularly assessed during therapy [see Warnings and Precautions (5.8)].

Pregnancy Registry

Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to lamivudine and zidovudine during pregnancy [see Use in Specific Populations (8.1)].
Lactation
Instruct women with HIV-1 infection not to breastfeed because HIV-1 can be passed to the baby in the breast milk [see Use in Specific Populations (8.2)].
Missed Dose

Instruct patients that if they miss a dose of lamivudine and zidovudine, to take it as soon as they remember. Advise patients not to double their next dose or take more than the prescribed dose [see Dosage and Administration (2)].
Trademarks are owned by or licensed to the ViiV Healthcare group of companies.
Distributed by:
Aurobindo Pharma USA, Inc.
279 Princeton-Hightstown Road
East Windsor, NJ 08520
Manufactured by:
Aurobindo Pharma Limited
Hyderabad-500 032, India
Revised: 02/2022

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 150 mg/300 mg (60 Tablet Bottle)

NDC 65862-036-60
Rx only
Lamivudine and
Zidovudine Tablets USP
150 mg/300 mg
AUROBINDO 60 Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 150 mg/300 mg Carton (6 x 10 Unit-dose Tablets)

NDC 65862-036-10 Rx only
Lamivudine and
Zidovudine Tablets USP
150 mg/300 mg
AUROBINDO 6 X 10 Unit-Dose Tablets

LAMIVUDINE AND ZIDOVUDINE lamivudine and zidovudine tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65862-036 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LAMIVUDINE (LAMIVUDINE) LAMIVUDINE 150 mg ZIDOVUDINE (ZIDOVUDINE) ZIDOVUDINE 300 mg

Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE HYPROMELLOSE 2910 (6 MPA.S) MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL 400 POLYSORBATE 80 SODIUM STARCH GLYCOLATE TYPE A POTATO TITANIUM DIOXIDE

Product Characteristics Color WHITE (White to Off-white) Score 2 pieces Shape CAPSULE (Modified Capsule Shaped, Biconvex) Size 17mm Flavor Imprint Code C;60 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:65862-036-60 60 TABLET, FILM COATED in 1 BOTTLE None 2 NDC:65862-036-10 6 BLISTER PACK in 1 CARTON contains a BLISTER PACK 2 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (65862-036-10)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077558 05/05/2017

Labeler — Aurobindo Pharma Limited (650082092)

Establishment
Name	Address	ID/FEI	Operations
Aurobindo Pharma Limited		918917642	ANALYSIS (65862-036), MANUFACTURE (65862-036)

Establishment
Name	Address	ID/FEI	Operations
Aurobindo Pharma Limited		650381903	ANALYSIS (65862-036), MANUFACTURE (65862-036)

Revised: 05/2022 Aurobindo Pharma Limited