COMBIVIR (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

COMBIVIR tablets, containing 150 mg lamivudine and 300 mg zidovudine, are white, scored, film‑coated, modified‑capsule-shaped tablets, debossed on both tablet faces, such that when broken in half, the full “GXFC3” code is present on both halves of the tablet (“GX” on one face and “FC3” on the opposite face of the tablet). They are available as follows:

60 Tablets/Bottle (NDC 49702-202-18).

Store between 2° and 30°C (36° and 86°F).

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 COMBIVIR 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 COMBIVIR and certain medications, including ganciclovir, interferon alfa, and ribavirin, may exacerbate the toxicity of zidovudine, a component of COMBIVIR [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 COMBIVIR is started [see Warnings and Precautions (5.7)].

Lipoatrophy

Advise patients that loss of subcutaneous fat may occur in patients receiving COMBIVIR 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 COMBIVIR 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 COMBIVIR, 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.

Manufactured for:

ViiV Healthcare
Research Triangle Park, NC 27709

by:

GlaxoSmithKline
Research Triangle Park, NC 27709

©2019 ViiV Healthcare group of companies or its licensor.

CMB:10PI

PRINCIPAL DISPLAY PANEL

NDC 49702-202-18

COMBIVIR

(lamivudine and zidovudine)

Tablets 150 mg/300 mg

Rx only

60 Tablets

Each tablet contains 150 mg of lamivudine and 300 mg of zidovudine.

Store between 2o and 30o C (36o and 86o F).

See prescribing information for dosage information.

Do not use if printed safety seal under cap is broken or missing.

Manufactured for:

ViiV Healthcare

Research Triangle Park, NC 27709

by:

GlaxoSmithKline

Research Triangle Park, NC 27709

Trademarks are owned or licensed by ViiV Healthcare.

©2018 ViiV Healthcare or licensor.

Made in UK

10000000149610 Rev. 9/18
Combivir 60 count label
(click image for full-size original)
COMBIVIR
lamivudine and zidovudine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49702-202
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, UNSPECIFIED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE
Product Characteristics
Color WHITE Score 2 pieces
Shape OVAL (modified-capsule-shaped tablets) Size 17mm
Flavor Imprint Code GXFC3
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49702-202-18 60 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020857 10/19/2010
Labeler — ViiV Healthcare Company (027295585)

Revised: 05/2019 ViiV Healthcare Company

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