Abacavir Oral Solution
Name: Abacavir Oral Solution
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What are some things I need to know or do while I take Abacavir Oral Solution?
For all patients taking abacavir oral solution:
- Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
- Avoid driving and doing other tasks or actions that call for you to be alert until you see how abacavir oral solution affects you.
- This medicine may raise the chance of heart attack. Talk with the doctor.
- Use care if you have risks for heart disease (high blood pressure, high cholesterol, overweight, high blood sugar or diabetes, cigarette smoking, man older than 40 years of age, other family members with early heart disease, woman after change of life). Talk with your doctor.
- Have blood work checked as you have been told by the doctor. Talk with the doctor.
- Read the warning card and carry it with you at all times. It tells the signs to watch for in case an allergy happens.
- If this medicine is stopped because you have an allergy to it, do not restart it. It may not be safe to restart abacavir oral solution. Throw away any of this medicine that you have not taken. If you are not sure how to throw away unused drugs, check with your pharmacist.
- If abacavir oral solution is stopped for any other reason, do not restart it without talking to the doctor. It could be very risky to restart on your own.
- Do not run out of this medicine.
- Talk with your doctor before you drink alcohol.
- This medicine is not a cure for HIV. Stay under the care of your doctor.
- This medicine does not stop the spread of diseases like HIV or hepatitis that are passed through blood or having sex. Do not have any kind of sex without using a latex or polyurethane condom. Do not share needles or other things like toothbrushes or razors. Talk with your doctor.
- Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using abacavir oral solution while you are pregnant.
- If giving to your child, the dose of this medicine may need to be changed as your child's weight changes. Have your child's weight checked often. Talk with the doctor before changing your child's dose.
Highlights for abacavir
ABACAVIR (a ba KA vir) is an antiretroviral medicine. It is used with other medicines to treat HIV. This medicine is not a cure for HIV. It will not stop the spread of HIV to others.
This drug also comes in other forms, including Oral tablet
This drug can cause serious side effects. See which side effects you should report to your doctor right away.
Know how to use your medication, and learn what might happen if you miss a dose.
Talk to your healthcare provider if you have any of these conditions.
Know what to watch for and get tips for reducing your risks while taking this drug.
Abacavir Side Effects
Side effects that you should report to your doctor or health care professional as soon as possible:
- allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
- breathing problems, cough
- fever or chills, sore throat
- nausea, vomiting, unusual stomach upset or pain
- redness, blistering, peeling or loosening of the skin, including inside the mouth
- unexplained weight loss
- unusually weak or tired
- weight gain around waist, back, or thinning of face, arms, legs
Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):
- loss of appetite
- trouble sleeping
How to Use abacavir
Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Use a specially marked spoon or dropper to measure each dose. Ask your pharmacist if you do not have one. Household spoons are not accurate. You may take this medicine with or without food. Take your medicine at regular intervals. Do not take your medicine more often than directed. For your anti-HIV therapy to work as well as possible, take each dose exactly as prescribed. Do not skip doses or stop your medicine even if you feel better. Skipping doses may make the HIV virus resistant to this medicine and other medicines. Do not stop taking except on your doctor's advice.
A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.
Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 3 months old for selected conditions, precautions do apply.What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:
- drink alcohol-containing drinks
- heart disease
- liver disease
- smoke tobacco
- an unusual or allergic reaction to abacavir, other medicines, foods, dyes, or preservatives
- pregnant or trying to get pregnant
If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.What should I watch for while using this medicine?
Visit your doctor or health care professional for regular check ups. Discuss any new symptoms with your doctor. You will need to have important blood work done while on this medicine.
HIV is spread to others through sexual or blood contact. Talk to your doctor about how to stop the spread of HIV.
A small number of people may have a severe allergy to this medicine. Some symptoms are a skin rash, fever, nausea, vomiting, stomach pain, severe tiredness, aches, or generally feeling sick. A list of these symptoms is on the Warning Card given to you by your pharmacist. You should carry this Warning Card with you. If you have these symptoms while taking this medicine, stop the medicine and call your doctor right away.
If you stop this medicine because you ran out of medicine or because you may have had an allergic reaction, talk to your doctor. Do not restart this medicine without your doctor's advice. Severe hypersensitivity reactions can occur within hours and may include life-threatening hypotension and death.Where should I keep my medicine?
Keep out of the reach of children.
Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Do not freeze. May be refrigerated. Throw away any unused medicine after the expiration date.
The following adverse reactions are discussed in other sections of the labeling:
• Serious and sometimes fatal hypersensitivity reaction [see Boxed Warning, Warnings and Precautions (5.1)].
• Lactic acidosis and severe hepatomegaly with steatosis [see Boxed Warning, Warnings and Precautions (5.2)].
• Immune reconstitution syndrome [see Warnings and Precautions (5.3)].
• Fat redistribution [see Warnings and Precautions (5.4)].
• Myocardial infarction [see Warnings and Precautions (5.5)].
Clinical Trials Experience in Adult Subjects
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
Serious and Fatal Abacavir-Associated Hypersensitivity Reactions
In clinical trials, serious and sometimes fatal hypersensitivity reactions have occurred with abacavir [see Boxed Warning, Warnings and Precautions (5.1)]. These reactions have been characterized by 2 or more of the following signs or symptoms: (1) fever; (2) rash; (3) gastrointestinal symptoms (including nausea, vomiting, diarrhea, or abdominal pain); (4) constitutional symptoms (including generalized malaise, fatigue, or achiness); (5) respiratory symptoms (including dyspnea, cough, or pharyngitis). Almost all abacavir hypersensitivity reactions include fever and/or rash as part of the syndrome.
Other signs and symptoms have included lethargy, headache, myalgia, edema, arthralgia, and paresthesia. Anaphylaxis, liver failure, renal failure, hypotension, adult respiratory distress syndrome, respiratory failure, myolysis, and death have occurred in association with these hypersensitivity reactions. Physical findings have included lymphadenopathy, mucous membrane lesions (conjunctivitis and mouth ulcerations), and maculopapular or urticarial rash (although some patients had other types of rashes and others did not have a rash). There were reports of erythema multiforme. Laboratory abnormalities included elevated liver chemistries, elevated creatine phosphokinase, elevated creatinine, and lymphopenia, and abnormal chest x-ray findings (predominantly infiltrates, which were localized).
Additional Adverse Reactions with Use of Abacavir
Therapy-Naive Adults: Treatment-emergent clinical adverse reactions (rated by the investigator as moderate or severe) with a greater than or equal to 5% frequency during therapy with abacavir 300 mg twice daily, lamivudine 150 mg twice daily, and efavirenz 600 mg daily compared with zidovudine 300 mg twice daily, lamivudine 150 mg twice daily, and efavirenz 600 mg daily from CNA30024 are listed in Table 2.
Table 2. Treatment-Emergent (All Causality) Adverse Reactions of at Least Moderate Intensity (Grades 2 to 4, Greater than or Equal to 5% Frequency) in Therapy-Naive Adults (CNA30024a) through 48 Weeks of Treatment
| Adverse Reaction ||Abacavir 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% |
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 zivdoudine group.
b Ten (3%) cases of suspected drug hypersensitivity were reclassified as not being due to abacavir following unblinding.
Treatment-emergent clinical adverse reactions (rated by the investigator as moderate or severe) with a greater than or equal to 5% frequency during therapy with abacavir 300 mg twice daily, lamivudine 150 mg twice daily, and zidovudine 300 mg twice daily compared with indinavir 800 mg 3 times daily, lamivudine 150 mg twice daily, and zidovudine 300 mg twice daily from CNA3005 are listed in Table 3.
Table 3. Treatment-Emergent (All Causality) Adverse Reactions of at Least Moderate Intensity (Grades 2 to 4, Greater than or Equal to 5% Frequency) in Therapy-Naive Adults (CNA3005) through 48 Weeks of Treatment
|Adverse Reaction ||Abacavir 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% |
Five subjects receiving abacavir in CNA3005 experienced worsening of pre-existing depression compared with none in the indinavir arm. The background rates of pre-existing depression were similar in the 2 treatment arms.
Abacavir Once Daily versus Abacavir Twice Daily (CNA30021): Treatment-emergent clinical adverse reactions (rated by the investigator as at least moderate) with a greater than or equal to 5% frequency during therapy with abacavir 600 mg once daily or abacavir 300 mg twice daily, both in combination with lamivudine 300 mg once daily and efavirenz 600 mg once daily from CNA30021, were similar. For hypersensitivity reactions, subjects receiving abacavir once daily showed a rate of 9% in comparison with a rate of 7% for subjects receiving abacavir twice daily. However, subjects receiving abacavir 600 mg once daily experienced a significantly higher incidence of severe drug hypersensitivity reactions and severe diarrhea compared with subjects who received abacavir 300 mg twice daily. Five percent (5%) of subjects receiving abacavir 600 mg once daily had severe drug hypersensitivity reactions compared with 2% of subjects receiving abacavir 300 mg twice daily. Two percent (2%) of subjects receiving abacavir 600 mg once daily had severe diarrhea while none of the subjects receiving abacavir 300 mg twice daily had this event.
Laboratory Abnormalities: Laboratory abnormalities (Grades 3 to 4) in therapy-naive adults during therapy with abacavir 300 mg twice daily, lamivudine 150 mg twice daily, and efavirenz 600 mg daily compared with zidovudine 300 mg twice daily, lamivudine 150 mg twice daily, and efavirenz 600 mg daily from CNA30024 are listed in Table 4.
Table 4. Laboratory Abnormalities (Grades 3 to 4) in Therapy-Naive Adults (CNA30024) through 48 Weeks of Treatment
Abacavir plus Lamivudine plus Efavirenz
Zidovudine plus Lamivudine plus Efavirenz
(n = 325)
Elevated CPK (>4 X ULN)
Elevated ALT (>5 X ULN)
Elevated AST (>5 X ULN)
Hypertriglyceridemia (>750 mg/dL)
Hyperamylasemia (>2 X ULN)
Neutropenia (ANC <750/mm3)
Anemia (Hgb ≤6.9 gm/dL)
Thrombocytopenia (Platelets <50,000/mm3)
Leukopenia (WBC ≤1,500/mm3)
ULN = Upper limit of normal.
n = Number of subjects assessed.
Laboratory abnormalities in CNA3005 are listed in Table 5.
Table 5. Treatment-Emergent Laboratory Abnormalities (Grades 3 to 4) in CNA3005
Abacavir plus Lamivudine/Zidovudine
(n = 262)
Indinavir plus Lamivudine/Zidovudine
(n = 264)
Elevated CPK (>4 x ULN)
ALT (>5 x ULN)
Hypertriglyceridemia (>750 mg/dL)
Hyperamylasemia (>2 x ULN)
Hyperglycemia (>13.9 mmol/L)
Anemia (Hgb ≤6.9 g/dL)
ULN = Upper limit of normal.
n = Number of subjects assessed.
The frequencies of treatment-emergent laboratory abnormalities were comparable between treatment groups in CNA30021.
Clinical Trials Experience in Pediatric Subjects
Therapy-Experienced Pediatric Subjects (Twice-Daily Dosing)
Treatment-emergent clinical adverse reactions (rated by the investigator as moderate or severe) with a greater than or equal to 5% frequency during therapy with abacavir 8 mg per kg twice daily, lamivudine 4 mg per kg twice daily, and zidovudine 180 mg per m2 twice daily compared with lamivudine 4 mg per kg twice daily and zidovudine 180 mg per m2 twice daily from CNA3006 are listed in Table 6.
Table 6. Treatment-Emergent (All Causality) Adverse Reactions of at Least Moderate Intensity (Grades 2 to 4, Greater than or Equal to 5% Frequency) in Therapy-Experienced Pediatric Subjects (CNA3006) through 16 Weeks of Treatment
|Adverse Reaction ||Abacavir 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% |
Laboratory Abnormalities: In CNA3006, laboratory abnormalities (anemia, neutropenia, liver function test abnormalities, and CPK elevations) were observed with similar frequencies as in a trial of therapy-naive adults (CNA30024). Mild elevations of blood glucose were more frequent in pediatric subjects receiving abacavir (CNA3006) as compared with adult subjects (CNA30024).
Other Adverse Events
In addition to adverse reactions and laboratory abnormalities reported in Tables 2, 3, 4, 5, and 6, other adverse reactions observed in the expanded access program were pancreatitis and increased GGT.
Pediatric Subjects Once-Daily verses Twice-Daily Dosing (COL105677): The safety of once-daily compared with twice-daily dosing of abacavir was assessed in the ARROW trial. Primary safety assessment in the ARROW trial was based on Grade 3 and Grade 4 adverse events. The frequency of Grade 3 and 4 adverse events was similar among subjects randomized to once-daily dosing compared with subjects randomized to twice-daily dosing. One event of Grade 4 hepatitis in the once-daily cohort was considered as uncertain causality by the investigator and all other Grade 3 or 4 adverse events were considered not related by the investigator.
The following adverse reactions have been identified during postmarketing use of abacavir. Because these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Body as a Whole
Redistribution/accumulation of body fat.
Lactic acidosis and hepatic steatosis [see Warnings and Precautions (5.2)].
Suspected Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported in patients receiving abacavir primarily in combination with medications known to be associated with SJS and TEN, respectively. Because of the overlap of clinical signs and symptoms between hypersensitivity to abacavir and SJS and TEN, and the possibility of multiple drug sensitivities in some patients, abacavir should be discontinued and not restarted in such cases.
There have also been reports of erythema multiforme with abacavir use [see Adverse Reactions (6.1)].
Use in specific populations
Pregnancy Exposure Registry
There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to abacavir during pregnancy. Healthcare Providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR)at 1-800-258-4263.
Available data from the APR show no difference in the overall risk of birth defects for abacavir compared with the background rate for birth defects of 2.7% in the Metropolitan Atlanta Congenital Defects Program (MACDP) reference population [see Data]. The APR uses the MACDP as the U.S. reference population for birth defects in the general population. The MACDP evaluates women and infants from a limited geographic area and does not include outcomes for births that occurred at less than 20 weeks gestation. The rate of miscarriage is not reported in the APR. The estimated background rate of miscarriage in clinically recognized pregnancies in the U.S. general population is 15% to 20%. The background risk for major birth defects and miscarriage for the indicated population is unknown.
In animal reproduction studies, oral administration of abacavir to pregnant rats during organogenesis resulted in fetal malformations and other embryonic and fetal toxicities at exposures 35 times the human exposure (AUC) at the recommended clinical daily dose. However, no adverse developmental effects were observed following oral administration of abacavir to pregnant rabbits during organogenesis, at exposures approximately 9 times the human exposure (AUC) at the recommended clinical dose [see Data].
Human Data: Based on prospective reports to the APR of over 2,000 exposures to abacavir during pregnancy resulting in live births (including over 1,000 exposed in the first trimester), there was no difference between the overall risk of birth defects for abacavir compared with the background birth defect rate of 2.7% in the U.S. reference population of the MACDP. The prevalence of defects in live births was 2.9% (95% CI: 2.0% to 4.1%) following first trimester exposure to abacavir-containing regimens and 2.7% (95% CI: 1.9% to 3.7%) following second/third trimester exposure to abacavir-containing regimens.
Abacavir has been shown to cross the placenta and concentrations in neonatal plasma at birth were essentially equal to those in maternal plasma at delivery [see Clinical Pharmacology (12.3)].
Animal Data: Abacavir was administered orally to pregnant rats (at 100, 300, and 1,000 mg per kg per day) and rabbits (at 125, 350, or 700 mg per kg per day) during organogenesis (on gestation Days 6 through 17 and 6 through 20, respectively). Fetal malformations (increased incidences of fetal anasarca and skeletal malformations) or developmental toxicity (decreased fetal body weight and crown-rump length) were observed in rats at doses up to 1,000 mg per kg per day, resulting in exposures approximately 35 times the human exposure (AUC) at the recommended daily dose. No developmental effects were observed in rats at 100 mg per kg per day, resulting in exposures (AUC) 3.5 times the human exposure at the recommended daily dose. In a fertility and early embryo-fetal development study conducted in rats (at 60, 160, or 500 mg per kg per day), embryonic and fetal toxicities (increased resorptions, decreased fetal body weights) or toxicities to the offspring (increased incidence of stillbirth and lower body weights) occurred at doses up to 500 mg per kg per day. No developmental effects were observed in rats at 60 mg per kg per day, resulting in exposures (AUC) approximately 4 times the human exposure at the recommended daily dose. Studies in pregnant rats showed that abacavir is transferred to the fetus through the placenta. In pregnant rabbits, no developmental toxicities and no increases in fetal malformations occurred at up to the highest dose evaluated, resulting in exposures (AUC) approximately 9 times the human exposure at the recommended dose.
The Centers for Disease Control and Prevention recommend that HIV-1-infected mothers in the United States not breastfeed their infants to avoid risking postnatal transmission of HIV-1 infection. Abacavir is present in human milk. There is no information on the effects of abacavir on the breastfed infant or the effects of the drug on milk production. Because of the potential for
(1) HIV-1 transmission (in HIV-negative infants), (2) developing viral resistance (in HIV-positive infants), and (3) serious adverse reactions in a breastfed infant, instruct mothers not to breastfeed if they are receiving abacavir.
The safety and effectiveness of abacavir have been established in pediatric patients aged 3 months and older. Use of abacavir is supported by pharmacokinetic trials and evidence from adequate and well-controlled trials of abacavir in adults and pediatric subjects [see Dosage and Administration (2.2), Adverse Reactions (6.2), Clinical Pharmacology (12.3), Clinical Studies (14.2)].
Clinical trials of abacavir did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, caution should be exercised in the administration of abacavir in elderly patient reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Patients with Impaired Hepatic Function
A dose reduction is required for patients with mild hepatic impairment (Child-Pugh Class A) [see Dosage and Administration (2.4)]. The safety, efficacy, and pharmacokinetic properties of abacavir have not been established in patients with moderate or severe hepatic impairment; therefore, abacavir is contraindicated in these patients [see Contraindications (4), Clinical Pharmacology (12.3)].
Abacavir Oral Solution Description
Abacavir sulfate is a synthetic carbocyclic nucleoside analogue with inhibitory activity against HIV-1. The chemical name of abacavir sulfate is (1S,4R)-4-[2-Amino-6-(cyclopropylamino)-9H-purin-9-yl]- 2-cyclopentene-1-methanol sulfate (salt) (2:1). Abacavir sulfate is the enantiomer with 1S, 4R absolute configuration on the cyclopentene ring. It has a molecular formula of (C14H18N6O)2•H2SO4 and a molecular weight of 670.74 daltons. It has the following structural formula:
Abacavir sulfate, USP is a white to off-white powder. Soluble in water, slightly soluble in methanol. It has an octanol per water (pH 3.3) partition coefficient (log P) of approximately 1.0 by UV-spectrometry at 25°C.f
Abacavir Oral Solution, USP is for oral administration. Each milliliter (1 mL) of Abacavir Oral Solution, USP contains abacavir sulfate USP equivalent to 20 mg of abacavir (i.e., 20 mg per mL) as active ingredient and the following inactive ingredients: anhydrous citric acid, methylparaben and propylparaben (added as preservatives), propylene glycol, saccharin sodium, sodium citrate (dihydrate), noncrystallizing sorbitol solution, strawberry and banana flavors and water.
In vivo, abacavir sulfate dissociates to its free base, abacavir. Dosages are expressed in terms of abacavir.
Package label.principal display panel
Abacavir Oral Solution Container
Abacavir Oral Solution Carton
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