ABACAVIR - abacavir sulfate tablet, film coated
Aurobindo Pharma Limited
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HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use abacavir sulfate safely and effectively. See full prescribing information for abacavir tablets USP.
Abacavir Tablets USP, for oral use Initial U.S. Approval: 1998 WARNING: HYPERSENSITIVITY REACTIONS, LACTIC ACIDOSIS, AND SEVERE HEPATOMEGALY See full prescribing information for complete boxed warning.
RECENT MAJOR CHANGESINDICATIONS AND USAGEAbacavir tablets USP, a nucleoside analogue, are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. (1) DOSAGE AND ADMINISTRATION
DOSAGE FORMS AND STRENGTHSTablets: 300 mg, scored (3) CONTRAINDICATIONSWARNINGS AND PRECAUTIONS
ADVERSE REACTIONS
To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. DRUG INTERACTIONSSee 17 for PATIENT COUNSELING INFORMATION and Medication Guide. Revised: 12/2012 |
Weight (kg) | Dosage Regimen Using Scored Tablet
| Total Daily Dose |
|
AM Dose
| PM Dose
|
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14 to 21 | ½ tablet (150 mg) | ½ tablet (150 mg) | 300 mg |
>21 to <30 | ½ tablet (150 mg) | 1 tablet (300 mg) | 450 mg |
≥30 | 1 tablet (300 mg) | 1 tablet (300 mg) | 600 mg |
In any patient treated with abacavir, the clinical diagnosis of hypersensitivity reaction must remain the basis of clinical decision-making. Even in the absence of the HLA-B*5701 allele, it is important to permanently discontinue abacavir and not rechallenge with abacavir if a hypersensitivity reaction cannot be ruled out on clinical grounds, due to the potential for a severe or even fatal reaction.
Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination, including abacavir and other antiretrovirals. A majority of these cases have been in women. Obesity and prolonged nucleoside exposure may be risk factors. Particular caution should be exercised when administering abacavir sulfate to any patient with known risk factors for liver disease; however, cases have also been reported in patients with no known risk factors. Treatment with abacavir sulfate should be suspended in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity (which may include hepatomegaly and steatosis even in the absence of marked transaminase elevations).
Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy, including abacavir sulfate. During the initial phase of combination antiretroviral treatment, patients whose immune systems respond may develop an inflammatory response to indolent or residual opportunistic infections (such as Mycobacterium avium infection, cytomegalovirus, Pneumocystis jirovecii pneumonia [PCP], or tuberculosis), which may necessitate further evaluation and treatment.
Autoimmune disorders (such as Graves’ disease, polymyositis, and Guillain-Barré syndrome) have also been reported to occur in the setting of immune reconstitution; however, the time to onset is more variable and can occur many months after initiation of treatment.
a This trial used double-blind ascertainment of suspected hypersensitivity reactions. During the blinded portion of the trial, suspected hypersensitivity to abacavir was reported by investigators in 9% of 324 subjects in the abacavir group and 3% of 325 subjects in the zidovudine group. b Ten (3%) cases of suspected drug hypersensitivity were reclassified as not being due to abacavir following unblinding. |
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Adverse Reaction | Abacavir Sulfate plus Lamivudine plus Efavirenz (n = 324) | Zidovudine plus Lamivudine plus Efavirenz (n = 325) |
Dreams/sleep disorders | 10% | 10% |
Drug hypersensitivity | 9% | <1%b
|
Headaches/migraine | 7% | 11% |
Nausea | 7% | 11% |
Fatigue/malaise | 7% | 10% |
Diarrhea | 7% | 6% |
Rashes | 6% | 12% |
Abdominal pain/gastritis/gastrointestinal signs and symptoms | 6% | 8% |
Depressive disorders | 6% | 6% |
Dizziness | 6% | 6% |
Musculoskeletal pain | 6% | 5% |
Bronchitis | 4% | 5% |
Vomiting | 2% | 9% |
Adverse Reaction | Abacavir Sulfate plus Lamivudine/Zidovudine (n = 262) | Indinavir plus Lamivudine/Zidovudine (n = 264) |
Nausea | 19% | 17% |
Headache | 13% | 9% |
Malaise and fatigue | 12% | 12% |
Nausea and vomiting | 10% | 10% |
Hypersensitivity reaction | 8% | 2% |
Diarrhea | 7% | 5% |
Fever and/or chills | 6% | 3% |
Depressive disorders | 6% | 4% |
Musculoskeletal pain | 5% | 7% |
Skin rashes | 5% | 4% |
Ear/nose/throat infections | 5% | 4% |
Viral respiratory infections | 5% | 5% |
Anxiety | 5% | 3% |
Renal signs/symptoms | <1% | 5% |
Pain (non-site-specific) | <1% | 5% |
ULN = Upper limit of normal. n = Number of subjects assessed. |
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Grade 3/4 Laboratory Abnormalities | Abacavir Sulfate plus Lamivudine plus Efavirenz (n = 324) | Zidovudine plus Lamivudine plus Efavirenz (n = 325) |
Elevated CPK (>4 X ULN) | 8% | 8% |
Elevated ALT (>5 X ULN) | 6% | 6% |
Elevated AST (>5 X ULN) | 6% | 5% |
Hypertriglyceridemia (>750 mg/dL) | 6% | 5% |
Hyperamylasemia (>2 X ULN) | 4% | 5% |
Neutropenia (ANC <750/mm3) | 2% | 4% |
Anemia (Hgb ≤6.9 gm/dL) | <1% | 2% |
Thrombocytopenia (Platelets <50,000/mm3) | 1% | <1% |
Leukopenia (WBC ≤1,500/mm3) | <1% | 2% |
ULN = Upper limit of normal. n = Number of subjects assessed. |
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Grade 3/4 Laboratory Abnormalities | Number of Subjects by Treatment Group |
|
Abacavir Sulfate plus Lamivudine/Zidovudine (n = 262) | Indinavir plus Lamivudine/Zidovudine (n = 264) |
|
Elevated CPK (>4 x ULN) | 18 (7%) | 18 (7%) |
ALT (>5 x ULN) | 16 (6%) | 16 (6%) |
Neutropenia (<750/mm3) | 13 (5%) | 13 (5%) |
Hypertriglyceridemia (>750 mg/dL) | 5 (2%) | 3 (1%) |
Hyperamylasemia (>2 x ULN) | 5 (2%) | 1 (<1%) |
Hyperglycemia (>13.9 mmol/L) | 2 (<1%) | 2 (<1%) |
Anemia (Hgb ≤6.9 g/dL) | 0 (0%) | 3 (1%) |
Adverse Reaction | Abacavir Sulfate plus Lamivudine plus Zidovudine (n = 102) | Lamivudine plus Zidovudine (n = 103) |
Fever and/or chills | 9% | 7% |
Nausea and vomiting | 9% | 2% |
Skin rashes | 7% | 1% |
Ear/nose/throat infections | 5% | 1% |
Pneumonia | 4% | 5% |
Headache | 1% | 5% |
a Subjects achieved and maintained confirmed HIV-1 RNA ≤50 copies/mL (<400 copies/mL) through Week 48 (Roche AMPLICOR Ultrasensitive HIV-1 MONITOR® standard test 1 PCR). b Includes viral rebound, insufficient viral response according to the investigator, and failure to achieve confirmed ≤50 copies/mL by Week 48. c Includes consent withdrawn, lost to follow up, protocol violations, those with missing data, clinical progression, and other. |
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Outcome | Abacavir Sulfate plus Lamivudine plus Efavirenz (n = 324) | Zidovudine plus Lamivudine plus Efavirenz (n = 325) |
Respondera
| 69% (73%) | 69% (71%) |
Virologic failuresb
| 6% | 4% |
Discontinued due to adverse reactions | 14% | 16% |
Discontinued due to other reasonsc
| 10% | 11% |
a Subjects achieved and maintained confirmed HIV-1 RNA <400 copies/mL. b Includes viral rebound and failure to achieve confirmed <400 copies/mL by Week 48. c Includes consent withdrawn, lost to follow up, protocol violations, those with missing data, clinical progression, and other. |
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Outcome | Abacavir Sulfate plus Lamivudine/Zidovudine (n = 262) | Indinavir plus Lamivudine/Zidovudine (n = 265) |
Respondera
| 49% | 50% |
Virologic failureb
| 31% | 28% |
Discontinued due to adverse reactions | 10% | 12% |
Discontinued due to other reasonsc
| 11% | 10% |
Screening HIV-1 RNA (copies/mL) | Abacavir Sulfate plus Lamivudine/Zidovudine (n = 262) | Indinavir plus Lamivudine/Zidovudine (n = 265) |
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<400 copies/mL | n | <400 copies/mL | n |
|
≥10,000 - ≤100,000 >100,000 | 50% 48% | 166 96 | 48% 52% | 165 100 |
a Subjects achieved and maintained confirmed HIV-1 RNA <50 copies/mL (<400 copies/mL) through Week 48 (Roche AMPLICOR Ultrasensitive HIV-1 MONITOR standard test version 1). b Includes viral rebound, failure to achieve confirmed <50 copies/mL (<400 copies/mL) by Week 48, and insufficient viral load response. c Includes consent withdrawn, lost to follow up, protocol violations, clinical progression, and other. |
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Outcome | Abacavir Sulfate 600 mg q.d. plus EPIVIR plus Efavirenz (n = 384) | Abacavir Sulfate 300 mg b.i.d. plus EPIVIR plus Efavirenz (n = 386) |
Respondera
| 64% (71%) | 65% (72%) |
Virologic failureb
| 11% (5%) | 11% (5%) |
Discontinued due to adverse reactions | 13% | 11% |
Discontinued due to other reasonsc
| 11% | 13% |
| Symptom(s)
|
Group 1
| Fever
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Group 2
| Rash
|
Group 3
| Nausea, vomiting, diarrhea, abdominal (stomach area) pain
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Group 4
| Generally ill feeling, extreme tiredness, or achiness
|
Group 5
| Shortness of breath, cough, sore throat
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If you stop your anti-HIV medicines, even for a short time, the amount of virus in your blood may increase and the virus may become harder to treat. If you take too much abacavir sulfate, call your healthcare provider or poison control center or go to the nearest hospital emergency room right away.
These changes may include:
The most common side effects of abacavir tablets in adults include:
The most common side effects of abacavir tablets in children include:
General information for safe and effective use of abacavir tablets
Avoid doing things that can spread HIV infection to others.
| Symptom(s)
|
Group 1
| Fever
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Group 2
| Rash
|
Group 3
| Nausea, vomiting, diarrhea, or abdominal (stomach area) pain
|
Group 4
| Generally ill feeling, extreme tiredness, or achiness
|
Group 5
| Shortness of breath, cough, or sore throat
|
ABACAVIR
abacavir sulfate tablet, film coated |
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Labeler - Aurobindo Pharma Limited (650082092) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
Aurobindo Pharma Limited | 918917642 | ANALYSIS(65862-073), MANUFACTURE(65862-073) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
Aurobindo Pharma Limited | 650381903 | ANALYSIS(65862-073), MANUFACTURE(65862-073) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
Aurobindo Pharma Limited | 918917626 | API MANUFACTURE(65862-073) |