abacavir

Contraindicated in:

Hypersensitivity (rechallenge may be fatal);
Presence of HLA-B*5701 allele (↑ risk of potentially fatal hypersensitivity reaction);
Moderate to severe hepatic impairment;
Concurrent use of antiretroviral combination products containing abacavir;
Lactation: Breastfeeding not recommended for women with HIV.

Use Cautiously in:

Coronary heart disease;
Women and obesity (↑ risk of lactic acidosis and severe hepatomegaly with steatosis);
OB: Considered a preferred NRTI for pregnant women who are antiretroviral-naive, who have had antiretroviral therapy in the past but are restarting, or who require a new antiretroviral regimen (due to poor tolerance or poor virologic response of current regimen);
Pedi: Children <3 mo (safety and effectiveness not established).

Adv. Reactions/Side Effects ⬆ ⬇

CV: MYOCARDIAL INFARCTION

Derm: rash

F and E: LACTIC ACIDOSIS

GI: diarrhea, nausea, vomiting, anorexia, HEPATOMEGALY (WITH STEATOSIS)

Neuro: headache, insomnia

Misc: HYPERSENSITIVITY REACTIONS, immune reconstitution syndrome

Interactions ⬆ ⬇

Drug-drug:

Alcohol↑ blood levels.
May ↓ methadone levels; slight ↑ in methadone dosing may be needed.
Use of fixed-dose abacavir/dolutegravir/lamivudine may ↑ riociguat levels and risk of toxicity; may need to ↓ riociguat dose.

Availability ⬆ ⬇

(Generic available)

Oral solution (strawberry/banana flavor): 20 mg/mL
Tablets: 300 mg
In combination with: lamivudine (generic only); lamivudine and zidovudine (generic only); lamivudine and dolutegravir (Triumeq). See Appendix [not included in this PDA edition].

Route/Dosage ⬆ ⬇

PO (Adults ): 300 mg twice daily.
PO (Children ≥3 mo): Oral solution: 8 mg/kg twice daily or 16 mg/kg once daily (not to exceed 600 mg/day); Tablets: 14–19 kg: 150 mg twice daily or 300 mg once daily; 20–24 kg: 150 mg in AM and 300 mg in PM or 450 mg once daily; ≥25 kg: 300 mg twice daily or 600 mg once daily.

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Converted inside cells to carbovir triphosphate, its active metabolite. Carbovir triphosphate inhibits the activity of HIV-1 reverse transcriptase, which in turn terminates viral DNA growth.

Therapeutic effects:

Slows the progression of HIV infection and decreases the occurrence of its sequelae.
Increases CD4 cell counts and decreases viral load.

Classifications ⬆ ⬇

Therapeutic Classification: antiretrovirals

Pharmacologic Classification: nucleoside reverse transcriptase inhibitors

Pharmacokinetics ⬆ ⬇

Absorption: Rapidly and extensively (83%) absorbed.

Distribution: Distributes into extravascular space and readily distributes into erythrocytes.

Metabolism/Excretion: Mostly metabolized by the liver; 1.2% excreted unchanged in urine.

Half-Life: 1.5 hr.

Time/Action Profile ⬆ ⬇

(blood levels)

ROUTE	ONSET	PEAK	DURATION
PO	unknown	unknown	unknown

Patient/Family Teaching ⬆ ⬇

Emphasize the importance of taking abacavir as directed. Must always be used in combination with other antiretroviral drugs. Do not take more than prescribed amount, and do not stop taking without consulting health care professional. Take missed doses as soon as remembered; do not double doses. Advise patient to read the Medication Guide prior to starting therapy and with each Rx refill in case of changes.
Instruct patient not to share abacavir with others.
Inform patient that abacavir does not cure AIDS or prevent associated or opportunistic infections. Abacavir may reduce risk of transmission of HIV to others through sexual contact or blood contamination. Caution patient to use a condom, and avoid sharing needles or donating blood to prevent spreading HIV to others. Advise patient that long-term effects of abacavir are unknown.
Advise patient of potential for hypersensitivity reactions that may result in death. Instruct patient to discontinue abacavir and notify health care professional immediately if symptoms of hypersensitivity or signs of immune reconstitution syndrome (signs and symptoms of an infection) occur. A warning card summarizing symptoms of abacavir hypersensitivity is provided with each prescription; instruct patient to carry card at all times.
Instruct patient to notify health care professional immediately if symptoms of lactic acidosis (tiredness or weakness, unusual muscle pain, trouble breathing, stomach pain with nausea and vomiting, cold especially in arms or legs, dizziness, fast or irregular heartbeat) or if signs of hepatotoxicity (yellow skin or whites of eyes, dark urine, light-colored stools, lack of appetite for several days or longer, nausea, abdominal pain) occur. These symptoms may occur more frequently in patients who are female, obese, or have been taking medications like abacavir for a long time.
Inform patient that redistribution and accumulation of body fat may occur, causing central obesity, dorsocervical fat enlargement (buffalo hump), peripheral wasting, breast enlargement, and cushingoid appearance.
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications, especially methadone and other antiretrovirals.
Rep: Advise women of reproductive potential to avoid breastfeeding during therapy and to notify health care professional if pregnancy is planned or suspected. Encourage women who become pregnant while taking abacavir to enroll in the Antiretroviral Pregnancy Registry by calling 1-800-258-4263.
Emphasize the importance of regular follow-up exams and blood counts to determine progress and monitor for side effects.

Pronunciation ⬆ ⬇

Code ⬆

NDC Code

0378- Mylan Pharmaceuticals Inc.
- 0378-4105- Abacavir Sulfate
  - 0378-4105-91- 1 BOTTLE, PLASTIC in 1 CARTON (0378-4105-91) / 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

0904- Major Pharmaceuticals
- 0904-6874- Abacavir
  - 0904-6874-04- 30 BLISTER PACK in 1 CARTON (0904-6874-04) / 1 TABLET, FILM COATED in 1 BLISTER PACK

0904- Major Pharmaceuticals
- 0904-6874- Abacavir
  - 0904-6874-06- 50 BLISTER PACK in 1 CARTON (0904-6874-06) / 1 TABLET, FILM COATED in 1 BLISTER PACK

17337- Olon SpA
- 17337-0001-
  - 17337-0001-1- 25 kg in 1 DRUM (17337-0001-1)

31722- Camber Pharmaceuticals, Inc.
- 31722-557- Abacavir
  - 31722-557-60- 60 TABLET in 1 BOTTLE (31722-557-60)

31722- Camber Pharmaceuticals, Inc.
- 31722-562- Abacavir
  - 31722-562-24- 240 mL in 1 BOTTLE (31722-562-24)

49702- ViiV Healthcare Company
- 49702-222- ZIAGEN
  - 49702-222-48- 1 BOTTLE in 1 CARTON (49702-222-48) / 240 mL in 1 BOTTLE

50268- AvPAK
- 50268-049- Abacavir
  - 50268-049-12- 20 BLISTER PACK in 1 BOX (50268-049-12) / 1 TABLET in 1 BLISTER PACK (50268-049-11)

51079- Mylan Institutional Inc.
- 51079-204- Abacavir Sulfate
  - 51079-204-06- 50 BLISTER PACK in 1 CARTON (51079-204-06) / 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-204-01)

52562- Chromo Laboratories India Private Limited
- 52562-036-
  - 52562-036-01- 50 kg in 1 CONTAINER (52562-036-01)

53104- Cipla Ltd.
- 53104-7558-
  - 53104-7558-1- 25 kg in 1 DRUM (53104-7558-1)

55111- Dr.Reddys Laboratories Limited
- 55111-920-
  55111-920-00- 1 kg in 1 DRUM (55111-920-00)

61187- ThermoFisher Scientific Cork
- 61187-010-
  61187-010-00- 20 kg in 1 DRUM (61187-010-00)

61876- DISHMAN CARBOGEN AMCIS LIMITED
- 61876-0718-
  61876-0718-1- 20 kg in 1 DRUM (61876-0718-1)

63379- Glaxo Operations UK Ltd
- 63379-049-
  63379-049-00- 20 kg in 1 DRUM (63379-049-00)

63379- Glaxo Operations UK Ltd
- 63379-095-
  63379-095-00- 16529 TABLET, FILM COATED in 1 DRUM (63379-095-00)

64980- Rising Pharma Holdings, Inc.
- 64980-405- Abacavir
  64980-405-24- 1 BOTTLE in 1 CARTON (64980-405-24) / 240 mL in 1 BOTTLE

65015- MYLAN LABORATORIES LIMITED
- 65015-640-
  - 65015-640-61- 100 kg in 1 DRUM (65015-640-61)

65085- Piramal Pharma Limited
- 65085-0024-
  65085-0024-1- 20 kg in 1 DRUM (65085-0024-1)

65862- Aurobindo Pharma Limited
- 65862-073-
  65862-073-18- 1800 TABLET, FILM COATED in 1 BAG (65862-073-18)

65862- Aurobindo Pharma Limited
- 65862-073- Abacavir
  65862-073-60- 60 TABLET, FILM COATED in 1 BOTTLE (65862-073-60)

65862- Aurobindo Pharma Limited
- 65862-089- Abacavir
  - 65862-089-24- 1 BOTTLE in 1 CARTON (65862-089-24) / 240 mL in 1 BOTTLE

65862- Aurobindo Pharma Limited
- 65862-256-
  - 65862-256-37- 50 kg in 1 DRUM (65862-256-37)

68084- American Health Packaging
- 68084-021- Abacavir
  68084-021-21- 30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-021-21) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-021-11)

68554- Hetero Labs Limited
- 68554-0032-
  - 68554-0032-1- 50 kg in 1 DRUM (68554-0032-1)

68554- Hetero Labs Limited
- 68554-0063-
  68554-0063-1- 50 kg in 1 DRUM (68554-0063-1)

69097- Cipla USA Inc.
- 69097-514- Abacavir
  69097-514-03- 60 TABLET, FILM COATED in 1 BOTTLE (69097-514-03)

72865- XLCare Pharmaceuticals Inc.
- 72865-167- Abacavir
  - 72865-167-60- 60 TABLET in 1 BOTTLE (72865-167-60)

82245- Viyash Life Sciences Private Limited
- 82245-0207-
  - 82245-0207-1- 20 kg in 1 CONTAINER (82245-0207-1)

84206- Tianish Laboratories Private Limited
- 84206-0001-
  84206-0001-1- 100 kg in 1 DRUM (84206-0001-1)

84206- Tianish Laboratories Private Limited
- 84206-0002-
  84206-0002-1- 100 kg in 1 DRUM (84206-0002-1)

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Indications ⬇

Contraind./Precautions ⬆ ⬇