Abacavir and Lamivudine (Page 8 of 8)

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Hypersensitivity Reactions
Inform patients:

  1. 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 lamivudine tablets, 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 and lamivudine tablets. The complete text of the Medication Guide is reprinted at the end of this document.
  2. to carry the Warning Card with them.
  3. how to identify a hypersensitivity reaction [see Warnings and Precautions ( 5.1), Medication Guide] .
  4. that if they develop symptoms consistent with a hypersensitivity reaction they should call their healthcare provider right away to determine if they should stop taking abacavir and lamivudine tablets.
  5. that a hypersensitivity reaction can worsen and lead to hospitalization or death if abacavir and lamivudine tablets are not immediately discontinued.
  6. to not restart abacavir and lamivudine tablets or any other abacavir-containing product following a hypersensitivity reaction because more severe symptoms can occur within hours and may include life-threatening hypotension and death.
  7. that if they have a hypersensitivity reaction, they should dispose of any unused abacavir and lamivudine tablets to avoid restarting abacavir.
  8. that a hypersensitivity reaction is usually reversible if it is detected promptly and abacavir and lamivudine tablets are stopped right away.
  9. that if they have interrupted abacavir and lamivudine tablets for reasons other than symptoms of hypersensitivity (for example, those who have an interruption in drug supply), a serious or fatal hypersensitivity reaction may occur with reintroduction of abacavir.
  10. to not restart abacavir and lamivudine tablets or any other abacavir-containing product without medical consultation and only if medical care can be readily accessed by the patient or others.

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 abacavir and lamivudine tablets if they develop clinical symptoms suggestive of lactic acidosis or pronounced hepatotoxicity [see Warnings and Precautions ( 5.2)] .

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 physician [see Warnings and Precautions ( 5.3)] .

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 ( 5.4)].

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 abacavir and lamivudine tablets are started [see Warnings and Precautions ( 5.5)].

Redistribution/Accumulation of Body Fat

Inform patients 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 ( 5.6)] .

Pregnancy Registry

Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to abacavir and lamivudine tablets 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 abacavir and lamivudine tablets, 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)].

Availability of Medication Guide

Instruct patients to read the Medication Guide before starting abacavir and lamivudine tablets and to re-read it each time the prescription is renewed. Instruct patients to inform their physician or pharmacist if they develop any unusual symptom, or if any known symptom persists or worsens.

All brand names listed are the registered trademarks of their respective owners and are not trademarks of AvKARE, Inc.

Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478

Mfg. Rev. 03/17 AV 02/18 (P)

Package/Label Display Panel, Part 1 of 3

Warning Card
(click image for full-size original)

Package/Label Display Panel, Part 2 of 3

Carton Label
(click image for full-size original)

Package/Label Display Panel, Part 3 of 3

Bottle Label
(click image for full-size original)

Abacavir and Lamivudine Tablets USP 600 mg/300 mg, 30s Bottle, Carton Text

NDC 42291-115-30

Abacavir and

Lamivudine Tablets USP

600 mg/300 mg

30 Tablets Rx Only

Each film-coated tablet contains 600 mg of abacavir as

abacavir sulfate, USP and 300 mg lamivudine, USP.

Usual Dosage: See package insert for full prescribing information.

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Notice to Authorized Dispenser: Each time abacavir and lamivudine tablets USP are dispensed, give the patient a Medication Guide and Warning Card from the carton.

Keep out of the reach of children.

Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478

Mfg. Rev. 07/16 AV 02/18 (P)

N3 42291 11530 9

ABACAVIR AND LAMIVUDINE abacavir and lamivudine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42291-115(NDC:0093-5382)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ABACAVIR SULFATE (ABACAVIR) ABACAVIR 600 mg
LAMIVUDINE (LAMIVUDINE) LAMIVUDINE 300 mg
Inactive Ingredients
Ingredient Name Strength
FD&C YELLOW NO. 6
HYPROMELLOSE 2910 (6 MPA.S)
FERRIC OXIDE YELLOW
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL 400
POLYSORBATE 80
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE
Product Characteristics
Color yellow Score no score
Shape OVAL (capsule-shaped) Size 19mm
Flavor Imprint Code 5382;TV
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42291-115-30 1 BOTTLE in 1 CARTON contains a BOTTLE
1 30 TABLET, FILM COATED in 1 BOTTLE This package is contained within the CARTON (42291-115-30)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079246 02/21/2018
Labeler — AvKARE, Inc. (796560394)

Revised: 04/2018 AvKARE, Inc.

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