Prescription Drug Information: Abacavir Sulfate (Page 7 of 8)
14.2 Pediatric Trials
Therapy-Experienced Pediatric Subjects
CNA3006 was a randomized, double-blind trial comparing abacavir 8 mg per kg twice daily plus lamivudine 4 mg per kg twice daily plus zidovudine 180 mg per m2 twice daily versus lamivudine 4 mg per kg twice daily plus zidovudine 180 mg per m2 twice daily. Two hundred and five therapy-experienced pediatric subjects were enrolled: female (56%), white (17%), black (50%), Hispanic (30%), median age of 5.4 years, baseline CD4+ cell percent greater than 15% (median = 27%), and median baseline plasma HIV-1 RNA of 4.6 log10 copies per mL. Eighty percent and 55% of subjects had prior therapy with zidovudine and lamivudine, respectively, most often in combination. The median duration of prior nucleoside analogue therapy was 2 years. At 16 weeks, the proportion of subjects responding based on plasma HIV-1 RNA less than or equal to 400 copies per mL was significantly higher in subjects receiving abacavir plus lamivudine plus zidovudine compared with subjects receiving lamivudine plus zidovudine, 13% versus 2%, respectively. Median plasma HIV-1 RNA changes from baseline were -0.53 log10 copies per mL in the group receiving abacavir plus lamivudine plus zidovudine compared with -0.21 log10 copies per mL in the group receiving lamivudine plus zidovudine. Median CD4+ cell count increases from baseline were 69 cells per mm3 in the group receiving abacavir plus lamivudine plus zidovudine and 9 cells per mm3 in the group receiving lamivudine plus zidovudine.
Once-Daily Dosing
ARROW (COL105677) was a 5-year randomized, multicenter trial which evaluated multiple aspects of clinical management of HIV-1 infection in pediatric subjects. HIV-1–infected, treatment-naive subjects aged 3 months to 17 years were enrolled and treated with a first-line regimen containing abacavir and lamivudine, dosed twice daily according to World Health Organization recommendations. After a minimum of 36 weeks of treatment, subjects were given the option to participate in Randomization 3 of the ARROW trial, comparing the safety and efficacy of once-daily dosing with twice-daily dosing of abacavir and lamivudine, in combination with a third antiretroviral drug, for an additional 96 weeks. Of the 1,206 original ARROW subjects, 669 participated in Randomization 3. Virologic suppression was not a requirement for participation at baseline for Randomization 3 (following a minimum of 36 weeks of twice-daily treatment), 75% of subjects in the twice-daily cohort were virologically suppressed compared with 71% of subjects in the once-daily cohort.
The proportions of subjects with HIV-1 RNA less than 80 copies per mL through 96 weeks are shown in Table 11. The differences between virologic responses in the two treatment arms were comparable across baseline characteristics for gender and age.
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Outcome | Abacavir plus Lamivudine Twice-Daily Dosing (n = 333) | Abacavir plus Lamivudine Once-Daily Dosing (n = 336) |
HIV-1 RNA < 80 copies/mL † | 70% | 67% |
HIV-1 RNA ≥ 80 copies/mL ‡ | 28% | 31% |
No virologic data | ||
Discontinued due to adverse event or death | 1% | < 1% |
Discontinued study for other reasons § | 0% | < 1% |
Missing data during window but on study | 1% | 1% |
16 HOW SUPPLIED/STORAGE AND HANDLING
Abacavir Tablets, USP are available containing abacavir sulfate, USP equivalent to 300 mg of abacavir.
The 300 mg tablets are peach, film-coated, capsule shaped, scored tablets debossed with M on one side of the score and 120 on the other side of the score on one side of the tablet and blank on the other side. They are available as follows:
NDC 0378-4105-91carton of one bottle containing 60 tablets
Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
Dispense in original container with attached prescribing information that contains the Medication Guide and a Warning Card.
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Hypersensitivity Reactions: Inform patients:
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- 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 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 tablets. The complete text of the Medication Guide is reprinted at the end of this document.
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- to carry the Warning Card with them.
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- how to identify a hypersensitivity reaction [see Warnings and Precautions (5.1), Medication Guide].
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- 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 tablets.
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- that a hypersensitivity reaction can worsen and lead to hospitalization or death if abacavir tablets are not immediately discontinued.
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- to not restart abacavir 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.
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- that if they have a hypersensitivity reaction, they should dispose of any unused abacavir tablets to avoid restarting abacavir.
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- that a hypersensitivity reaction is usually reversible if it is detected promptly and abacavir tablets are stopped right away.
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- that if they have interrupted abacavir 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.
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- to not restart abacavir 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 tablets if they develop clinical symptoms suggestive of lactic acidosis or pronounced hepatotoxicity [see Warnings and Precautions (5.2)].
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 tablets are started [see Warnings and Precautions (5.3)].
Pregnancy Registry: Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to abacavir 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 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 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.
Medication Guide
Abacavir Tablets, USP(a bak′ a vir) | |||||
What is the most important information I should know about abacavir tablets?
Abacavir tablets can cause serious side effects, including:
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Symptom(s) | |||||
Group 1 | Fever | ||||
Group 2 | Rash | ||||
Group 3 | Nausea, vomiting, diarrhea, abdominal (stomach area) pain | ||||
Group 4 | Generally ill feeling, extreme tiredness, or achiness | ||||
Group 5 | Shortness of breath, cough, sore throat | ||||
If your healthcare provider tells you that you can take abacavir tablets again, start taking them when you are around medical help or people who can call a healthcare provider if you need one. | |||||
What is abacavir?
Abacavir is a prescription HIV-1 (Human Immunodeficiency Virus type 1) medicine used with other antiretroviral medicines to treat HIV-1 infection. HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS). The safety and effectiveness of abacavir has not been established in children under 3 months of age. When used with other antiretroviral medicines to treat HIV-1 infection, abacavir tablets may help:
Reducing the amount of HIV-1 and increasing the CD4+ (T) cells in your blood may help improve your immune system. This may reduce your risk of death or getting infections that can happen when your immune system is weak (opportunistic infections).
Abacavir tablets do not cure HIV-1 infection or AIDS. You must keep taking HIV-1 medicines to control HIV-1 infection and decrease HIV-related illnesses. | |||||
Who should not take abacavir tablets? Do not take abacavir tablets if you:
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What should I tell my healthcare provider before taking abacavir tablets? Before you take abacavir tablets, tell your healthcare provider if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some medicines interact with abacavir tablets. Keep a list of your medicines to show your healthcare provider and pharmacist. You can ask your healthcare provider or pharmacist for a list of medicines that interact with abacavir tablets. Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take abacavir tablets with other medicines. Tell your healthcare provider if you take:
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How should I take abacavir tablets?
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What are the possible side effects of abacavir tablets?
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You may be more likely to get lactic acidosis or serious liver problems if you are female or very overweight (obese). | |||||
The most common side effects of abacavir tablets in adults include: | |||||
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The most common side effects of abacavir in children include: | |||||
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Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of abacavir tablets. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. | |||||
How should I store abacavir tablets?
Keep abacavir tablets and all medicines out of the reach of children. | |||||
General information for safe and effective use of abacavir tablets
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use abacavir tablets for a condition for which they were not prescribed. Do not give abacavir tablets to other people, even if they have the same symptoms that you have. They may harm them. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for the information about abacavir tablets that is written for health professionals. For more information, call Mylan at 1-877-446-3679 (1-877-4-INFO-RX). | |||||
What are the ingredients in abacavir tablets? Active ingredient: abacavir Inactive ingredients: Tablets: colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, red iron oxide, sodium starch glycolate (potato), titanium dioxide and yellow iron oxide. Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A. Manufactured by: Mylan Laboratories Limited, Hyderabad — 500 096, India The brands listed are trademarks of their respective owners. |
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.
Manufactured by:
Mylan Laboratories Limited
Hyderabad — 500 096, India
75078386
Revised: 1/2021
MX:ABCV:R8
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