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Ziagen (Abacavir Sulfate) side effects drug center

 

PROFESSIONAL

CONSUMER

SIDE EFFECTS

 

Ziagen Side Effects Center

What Is Ziagen?

Ziagen (abacavir sulfate) is an antiviral medication used to treat HIV, which causes the acquired immunodeficiency syndrome (AIDS). Ziagen is not a cure for HIV or AIDS.

What Are Side Effects of Ziagen?

Common side effects of Ziagen include:

  • trouble sleeping,
  • loss of appetite,
  • strange dreams,
  • headache,
  • ear pain,
  • cold symptoms (stuffy nose, sneezing, sinus pain), or
  • changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and trunk).

Tell your doctor if you have any serious side effects of Ziagen including:

  • unexplained weight loss,
  • persistent muscle aches or weakness,
  • joint pain,
  • numbness or tingling of the hands/feet/arms/legs,
  • severe tiredness,
  • vision changes,
  • severe or persistent headaches,
  • signs of infection (such as fever, chills, trouble breathing, cough, non-healing skin sores),
  • signs of an overactive thyroid (such as irritability, nervousness, heat intolerance, fast/pounding/irregular heartbeat, bulging eyes, unusual growth in the neck/thyroid known as a goiter),
  • signs of a certain nerve problem known as Guillain-Barre Syndrome (such as difficulty breathing/swallowing/moving your eyes, drooping face, paralysis, slurred speech), or
  • mental/mood changes (depression, anxiety).

Dosage for Ziagen

The recommended oral dose of Ziagen for adults is 600 mg daily, administered as either 300 mg twice daily or 600 mg once daily, in combination with other antiretroviral agents. Pediatric dose is determined by the child's weight.

What Drugs, Substances, or Supplements Interact with Ziagen?

Ziagen may interact with methadone. Tell your doctor all medications and supplements you use.

Ziagen During Pregnancy and Breastfeeding

During pregnancy, Ziagen should be used only when prescribed. HIV medicines are usually given to pregnant women with HIV. Treatment is shown to decrease the risk of HIV transmission to the baby. This drug may be part of that treatment. Discuss the risks and benefits with your doctor. It is not known if this medication passes into breast milk. Because breast milk can transmit HIV, do not breastfeed.

Additional Information

Our Ziagen (abacavir sulfate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Ziagen Consumer Information

Stop using abacavir and call your doctor at once if you have symptoms of an allergic reaction from two or more of these specific side effect groups:

  • Group 1 - fever;
  • Group 2 - rash;
  • Group 3 - nausea, vomiting, diarrhea, stomach pain;
  • Group 4 - general ill feeling, extreme tiredness, body aches;
  • Group 5 - shortness of breath, cough, sore throat.

Once you have had an allergic reaction to abacavir, you must never use it again. If you stop taking abacavir for any reason, talk to your doctor before you start taking the medication again.

Abacavir can cause other serious side effects that may not be signs of an allergic reaction. Call your doctor at once if you have:

  • severe upper stomach pain, nausea, vomiting, loss of appetite;
  • swelling around your midsection;
  • dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes);
  • unusual tiredness; or
  • chest pain or pressure, pain spreading to your jaw or shoulder.

Mild symptoms of lactic acidosis may worsen over time, and this condition can be fatal. Get emergency medical help if you have: unusual muscle pain, trouble breathing, stomach pain, vomiting, irregular heart rate, dizziness, feeling cold, or feeling very weak or tired.

Abacavir affects your immune system, which may cause certain side effects (even weeks or months after you've taken this medicine). Tell your doctor if you have:

  • signs of a new infection--fever, night sweats, swollen glands, cold sores, cough, wheezing, diarrhea, weight loss;
  • trouble speaking or swallowing, problems with balance or eye movement, weakness or prickly feeling; or
  • swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence.

Common side effects may include:

  • feeling tired;
  • sleep problems, strange dreams;
  • headache, tiredness, fever, chills, general ill feeling;
  • nausea or vomiting;
  • rash; or
  • (in children) stuffy nose, sneezing, sore throat, ear pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Ziagen (Abacavir Sulfate)

 

Ziagen Professional Information

SIDE EFFECTS

The following adverse reactions are discussed in other sections of the labeling:

  • Serious and sometimes fatal hypersensitivity reactions [see BOX WARNING, WARNINGS AND PRECAUTIONS].
  • Lactic acidosis and severe hepatomegaly with steatosis [see WARNINGS AND PRECAUTIONS].
  • Immune reconstitution syndrome [see WARNINGS AND PRECAUTIONS].
  • Myocardial infarction [see WARNINGS AND PRECAUTIONS].

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 BOX WARNING, WARNINGS AND PRECAUTIONS]. 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 ZIAGEN

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 ZIAGEN 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 2-4, Greater than or Equal to 5% Frequency) in Therapy-Naive Adults (CNA30024a) through 48 Weeks of Treatment

Adverse ReactionZIAGEN plus Lamivudine plus Efavirenz
(n = 324)		Zidovudine plus Lamivudine plus Efavirenz
(n = 325)
Dreams/sleep disorders10%10%
Drug hypersensitivity9%<1%b
Headaches/migraine7%11%
Nausea7%11%
Fatigue/malaise7%10%
Diarrhea7%6%
Rashes6%12%
Abdominal pain/gastritis/gastrointestinal signs and symptoms6%8%
Depressive disorders6%6%
Dizziness6%6%
Musculoskeletal pain6%5%
Bronchitis4%5%
Vomiting2%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 zidovudine 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 ZIAGEN 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 2-4, Greater than or Equal to 5% Frequency) in Therapy-Naive Adults (CNA3005) through 48 Weeks of Treatment

Adverse ReactionZIAGEN plus Lamivudine/Zidovudine
(n = 262)		Indinavir plus Lamivudine/Zidovudine
(n = 264)
Nausea19%17%
Headache13%9%
Malaise and fatigue12%12%
Nausea and vomiting10%10%
Hypersensitivity reaction8%2%
Diarrhea7%5%
Fever and/or chills6%3%
Depressive disorders6%4%
Musculoskeletal pain5%7%
Skin rashes5%4%
Ear/nose/throat infections5%4%
Viral respiratory infections5%5%
Anxiety5%3%
Renal signs/symptoms<1%5%
Pain (non-site-specific)<1%5%

Five subjects receiving ZIAGEN 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.

ZIAGEN Once Daily versus ZIAGEN 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 ZIAGEN 600 mg once daily or ZIAGEN 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 ZIAGEN once daily showed a rate of 9% in comparison with a rate of 7% for subjects receiving ZIAGEN twice daily. However, subjects receiving ZIAGEN 600 mg once daily experienced a significantly higher incidence of severe drug hypersensitivity reactions and severe diarrhea compared with subjects who received ZIAGEN 300 mg twice daily. Five percent (5%) of subjects receiving ZIAGEN 600 mg once daily had severe drug hypersensitivity reactions compared with 2% of subjects receiving ZIAGEN 300 mg twice daily. Two percent (2%) of subjects receiving ZIAGEN 600 mg once daily had severe diarrhea while none of the subjects receiving ZIAGEN 300 mg twice daily had this event.

Laboratory Abnormalities

Laboratory abnormalities (Grades 3-4) in therapy-naive adults during therapy with ZIAGEN 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 3-4) in Therapy-Naive Adults (CNA30024) through 48 Weeks of Treatment

Grade 3/4 Laboratory AbnormalitiesZIAGEN 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.

Laboratory abnormalities in CNA3005 are listed in Table 5.

Table 5. Treatment-Emergent Laboratory Abnormalities (Grades 3-4) in CNA3005

Grade 3/4 Laboratory AbnormalitiesZIAGEN plus Lamivudine/Zidovudine
(n = 262)		Indinavir plus Lamivudine/Zidovudine
(n = 264)
Elevated CPK (>4 x ULN)18 (7%)18 (7%)
ALT (>5.0 x ULN)16 (6%)16 (6%)
Neutropenia (<750/mm3)13 (5%)13 (5%)
Hypertriglyceridemia (>750 mg/dL)5 (2%)3 (1%)
Hyperamylasemia (>2.0 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%)
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 ZIAGEN 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 2-4, Greater than or Equal to 5% Frequency) in Therapy-Experienced Pediatric Subjects (CNA3006) through 16 Weeks of Treatment

Adverse ReactionZIAGEN plus Lamivudine plus Zidovudine
(n = 102)		Lamivudine plus Zidovudine
(n = 103)
Fever and/or chills9%7%
Nausea and vomiting9%2%
Skin rashes7%1%
Ear/nose/throat infections5%1%
Pneumonia4%5%
Headache1%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 ZIAGEN (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 versus Twice-Daily Dosing (COL105677)

The safety of once-daily compared with twice-daily dosing of ZIAGEN 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.

Postmarketing Experience

The following adverse reactions have been identified during postmarketing use of ZIAGEN. 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 exposures.

Body As A Whole

Redistribution/accumulation of body fat.

Cardiovascular

Myocardial infarction.

Hepatic

Lactic acidosis and hepatic steatosis [see WARNINGS AND PRECAUTIONS].

Skin

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 Clinical Trials Experience In Adult Subjects].

Read the entire FDA prescribing information for Ziagen (Abacavir Sulfate)

&Copy; Ziagen Patient Information is supplied by Cerner Multum, Inc. and Ziagen Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.