RETROVIR (Page 6 of 6)

14.2 Pediatric Patients

ACTG 300 was a multi-center, randomized, double-blind study that provided for comparison of EPIVIR plus RETROVIR to didanosine monotherapy. A total of 471 symptomatic, HIV-1-infected therapy-naive pediatric patients were enrolled in these 2 treatment arms. The median age was 2.7 years (range: 6 weeks to 14 years), the mean baseline CD4+ cell count was 868 cells/mm3 , and the mean baseline plasma HIV-1 RNA was 5.0 log10 copies/mL. The median duration that patients remained on study was approximately 10 months. Results are summarized in Table 10.

Table 10. Number of Patients (%) Reaching a Primary Clinical Endpoint (Disease Progression or Death)
Endpoint

EPIVIR plus RETROVIR

Didanosine

HIV disease progression or death (total) 15 (6.4%) 37 (15.7%)
Physical growth failure 7 (3.0%) 6 (2.6%)
Central nervous system deterioration 4 (1.7%) 12 (5.1%)
CDC Clinical Category C 2 (0.8%) 8 (3.4%)
Death 2 (0.8%) 11 (4.7%)

14.3 Prevention of Maternal-Fetal HIV-1 Transmission

The utility of RETROVIR for the prevention of maternal-fetal HIV-1 transmission was demonstrated in a randomized, double-blind, placebo-controlled trial (ACTG 076) conducted in HIV-1-infected pregnant women with CD4+ cell counts of 200 to 1,818 cells/mm3 (median in the treated group: 560 cells/mm3) who had little or no previous exposure to RETROVIR. Oral RETROVIR was initiated between 14 and 34 weeks of gestation (median 11 weeks of therapy) followed by IV administration of RETROVIR during labor and delivery. Following birth, neonates received oral RETROVIR Syrup for 6 weeks. The study 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 RETROVIR and the group receiving placebo. Of 363 neonates evaluated in the study, the estimated risk of HIV-1 infection was 7.8% in the group receiving RETROVIR and 24.9% in the placebo group, a relative reduction in transmission risk of 68.7%. RETROVIR 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

RETROVIR Tablets 300 mg (biconvex, white, round, film-coated) containing 300 mg zidovudine, one side engraved “GX CW3” and “300” on the other side.

Bottle of 60 (NDC 0173-0501-00).

Store at 15° to 25°C (59° to 77°F).

RETROVIR Capsules 100 mg (white, opaque cap and body) containing 100 mg zidovudine and printed with “Wellcome” and unicorn logo on cap and “Y9C” and “100” on body.

Bottles of 100 (NDC 0173-0108-55).

Store at 15° to 25°C (59° to 77°F) and protect from moisture.

RETROVIR Syrup (colorless to pale yellow, strawberry-flavored) containing 50 mg zidovudine in each teaspoonful (5 mL).

Bottle of 240 mL (NDC 0173-0113-18) with child-resistant cap.

Store at 15° to 25°C (59° to 77°F).

17 PATIENT COUNSELING INFORMATION

17.1 Information About Therapy With RETROVIR

Neutropenia and Anemia: Patients should be informed that the major toxicities of RETROVIR are neutropenia and/or anemia. The frequency and severity of these toxicities are greater in patients with more advanced disease and in those who initiate therapy later in the course of their infection. Patients should be informed that if toxicity develops, they may require transfusions or drug discontinuation. Patients should be informed of the extreme importance of having their blood counts followed closely while on therapy, especially for patients with advanced symptomatic HIV-1 disease [see Boxed Warning, Warnings and Precautions (5.1)].

Myopathy: Patients should be informed that myopathy and myositis with pathological changes, similar to that produced by HIV-1 disease, have been associated with prolonged use of RETROVIR [see Boxed Warning, Warnings and Precautions (5.2)].

Lactic Acidosis/Hepatomegaly: Patients should be informed that some HIV medicines, including RETROVIR, can cause a rare, but serious condition called lactic acidosis with liver enlargement (hepatomegaly) [see Boxed Warning, Warnings and Precautions (5.3)].

HIV-1/HCV Co-Infection: Patients with HIV-1/HCV co-infection should be informed 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 (5.4)].

Redistribution/Accumulation of Body Fat: Patients should be informed that redistribution or accumulation of body fat may occur in patients receiving antiretroviral therapy and that the cause and long-term health effects of these conditions are not known at this time [see Warnings and Precautions (5.7)].

Common Adverse Reactions: Patients should be informed that the most commonly reported adverse reactions in adult patients being treated with RETROVIR were headache, malaise, nausea, anorexia, and vomiting. The most commonly reported adverse reactions in pediatric patients receiving RETROVIR were fever, cough, and digestive disorders. Patients also should be encouraged to contact their physician if they experience muscle weakness, shortness of breath, symptoms of hepatitis or pancreatitis, or any other unexpected adverse events while being treated with RETROVIR [see Adverse Reactions (6)].

Drug Interactions: Patients should be cautioned about the use of other medications, including ganciclovir, interferon alfa, and ribavirin, which may exacerbate the toxicity of RETROVIR [see Drug Interactions (7)].

Pregnancy: Pregnant women considering the use of RETROVIR during pregnancy for prevention of HIV-1 transmission to their infants should be informed that transmission may still occur in some cases despite therapy. The long-term consequences of in utero and infant exposure to RETROVIR are unknown, including the possible risk of cancer [see Use in Specific Populations (8.1)].

HIV-1-infected pregnant women should be informed not to breastfeed to avoid postnatal transmission of HIV to a child who may not yet be infected [see Use in Specific Populations (8.3)].

Information About Therapy With RETROVIR: RETROVIR is not a cure for HIV-1 infection, and patients may continue to acquire illnesses associated with HIV-1 infection, including opportunistic infections. Therefore, patients should be informed to seek medical care for any significant change in their health status.

Patients should be informed of the importance of taking RETROVIR exactly as prescribed. They should be informed not to share medication and not to exceed the recommended dose. Patients should be informed that the long-term effects of RETROVIR are unknown at this time.

Patients should be informed that therapy with RETROVIR has not been shown to reduce the risk of transmission of HIV-1 to others through sexual contact or blood contamination.

RETROVIR, COMBIVIR, EPIVIR, and TRIZIVIR are registered trademarks of GlaxoSmithKline.

GlaxoSmithKline
Research Triangle Park, NC 27709

©2010, GlaxoSmithKline. All rights reserved.

May 2010
RTT:3PI

Principal Display Panel

NDC 0173-0108-55

RETROVIR®

(zidovudine)

CAPSULES

100 mg

Rx only

100 Capsules

Each capsule contains 100 mg of zidovudine.

See prescribing information for dosing information.

Store at 15o to 25o C (59o to 77o F) and protect from moisture. Dispense in a tight container as defined in the USP.

GlaxoSmithKline

Research Triangle Park, NC 27709

Made in South Korea

10000000076415 Rev. 1/10

Retrovir Capsule 100mg label
(click image for full-size original)

Principal Display Panel

NDC 0173-0501-00

RETROVIR®

(zidovudine)

TABLETS

300 mg

Rx only

60 Tablets

Each tablet contains 300 mg of zidovudine.

See package insert for dosage information.

Store at 15o to 25o C (59o to 77o F).

GlaxoSmithKline

Research Triangle Park, NC 27709

Made in England

10000000076416 Rev. 1/10

Retrovir Tablet 300mg Label
(click image for full-size original)

Principal Display Panel

NDC 0173-0113-18

RETROVIR®

(zidovudine)

SYRUP

Rx only

240 mL

Each 5 mL (1 teaspoonful) contains zidovudine 50 mg and sodium benzoate 0.2% added as a preservative.

See prescribing information for dosage information.

Store at 15o to 25o C (59o to 77o F).

GlaxoSmithKline

Research Triangle Park, NC 27709

Made in South Korea

A074003 Rev. 10/09

Retrovir Syrup 10mg/mL Label
(click image for full-size original)

RETROVIR
zidovudine capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0173-0108
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZIDOVUDINE (ZIDOVUDINE) ZIDOVUDINE 100 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE A POTATO
FERRIC OXIDE BLACK
DIMETHICONE
GELATIN
SHELLAC
LECITHIN, SOYBEAN
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (opaque cap and body) Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code Wellcome;Y9C;100
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0173-0108-55 100 CAPSULE (CAPSULE) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019655 06/22/1987 06/30/2013
RETROVIR
zidovudine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0173-0501
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZIDOVUDINE (ZIDOVUDINE) ZIDOVUDINE 300 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 10mm
Flavor Imprint Code GX;CW3;300
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0173-0501-00 60 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020518 10/14/1996 03/14/2013
RETROVIR
zidovudine syrup
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0173-0113
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZIDOVUDINE (ZIDOVUDINE) ZIDOVUDINE 50 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM BENZOATE
CITRIC ACID
GLYCERIN
SUCROSE
SODIUM HYDROXIDE
Product Characteristics
Color YELLOW (colorless to pale yellow) Score
Shape Size
Flavor STRAWBERRY Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0173-0113-18 240 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019910 10/10/1989 09/30/2013
Labeler — GlaxoSmithKline LLC (167380711)

Revised: 07/2011 GlaxoSmithKline LLC

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