Hepatitis B Drug Summary

• Post-injection local reactions, hypersensitivity reactions

• Monitor serum anti-HBs level at least every 2-4 weeks for 6 months; serum HBsAg, LFT, and infusion-related adverse events (liver transplant)

6 months

• Influenza-like symptoms (fatigue, fever, headache, myalgia, arthralgia); Neuropsychiatric effects (depression, mood swings, irritability, somnolence); Hematological effects (granulocytopenia, thrombocytopenia); CV effects (chest pain, edema, hypertension); Other effects (pain at injection site, dyspepsia, alopecia, thyroid function abnormalities)
• May cause or aggravate fatal or life-threatening infectious or ischemic disorders

• Contraindicated in patients with decompensated liver disease, autoimmune hepatitis
• Use with caution in patients with hepatic or renal impairment, depression or psychiatric disorders, cardiovascular disease, arrhythmias, hypertension, pre-existing thyroid disease
• Maintain adequate hydration during treatment
• Withdraw drug if jaundice occurs
• Monitor LFT

12 months

• GI effects (nausea, flatulence, diarrhea, dyspepsia, abdominal pain); Dermatologic effects (skin rashes, pruritus); Respiratory effects (cough, pharyngitis, sinusitis); Other effect (headache)
• At high doses: Nephrotoxicity (renal tubular dysfunction resembling Fanconi syndrome, deterioration in renal function)

• Use with caution in patients with hepatic or renal impairment
• May need to reduce dosage in patients with renal impairment

• GI effects (dyspepsia, abdominal pain); Other effects (upper respiratory infections, asthenia, headache)

• Contraindicated in patients with renal impairment
• Use with caution in patients with lactic acidosis and severe hepatomegaly with steatosis

• CNS effects (headache, fatigue, dizziness, somnolence); GI effects (nausea/vomiting, dyspepsia, increase in ALT that generally resolves with continued treatment); Other effects (edema, ascites, hyperglycemia)

• It is advised that patients should be immunized with meningococcal vaccines at least 2 weeks prior to initiation of therapy
• Use with caution in patients with active infection

• GI disturbances (abdominal pain, nausea/vomiting, diarrhea; mild increases in ALT levels that generally resolves with continued treatment); Respiratory effects (cough, nasal symptoms); CNS effects (malaise, fever); Musculoskeletal effects (arthralgia, musculoskeletal pain, peripheral neuropathy); Other effects (rash, alopecia)

• Use with caution in patients with hepatomegaly and hepatic impairment

• CNS effects (dizziness, headache); GI effects (diarrhea, increased blood amylase, nausea; increased ALT levels that generally resolves with continued treatment); Other effects (rash, fatigue)

• Use with caution in patients with renal impairment

• Significant reactions: Acute renal failure, Fanconi syndrome, lactic acidosis, hepatomegaly with steatosis
• GI effects (abdominal pain, nausea); Other effects (headache, fatigue, cough, back pain)

• Test patients for HIV-1 infection prior to initiation of treatment
• Due to the risk of developing HIV-1 resistance in patients coinfected with HBV and HIV-1, monotherapy is not recommended for the treatment of HIV-1 infection
• Assess serum creatinine and phosphorous, estimated CrCl, and urine glucose and protein before initiating and during therapy in all patients as clinically appropriate
• Not recommended in patients with decompensated hepatic impairment or end-stage renal disease
• Discontinue in patients who develop clinically significant decreases in renal function or evidence of Fanconi syndrome and in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity; discontinuation of therapy may result in severe acute exacerbations of hepatitis B
• Patients who discontinue therapy should be closely monitored with both clinical and laboratory follow-up for at least several months after stopping treatment

• Significant reactions: Decreased bone mineral density, acute renal failure, Fanconi syndrome, lactic acidosis, hepatomegaly with steatosis
• CNS effects (insomnia, dizziness, depression); GI disturbances (nausea, flatulence, diarrhea, abdominal pain); Other effects (pruritus, fatigue)

• Perform HIV test prior to therapy
• Due to the risk of developing HIV-1 resistance in patients coinfected with HBV and HIV-1, monotherapy is not recommended for the treatment of HIV-1 infection
• Use with caution in patients with hepatic or renal impairment
• May need to reduce dosage in patients with renal impairment
• Do not use concurrently with other nucleotide reverse transcriptase inhibitors

• Post-injection local reactions; CNS effects (fever, headache, malaise, dizziness, sleep disturbance); GI effect (abdominal pain); Hypersensitivity reactions

• Give by SC route in patients with impaired immunity or with bleeding disorders

• Post-injection local reactions; CNS effects (fever, headache, malaise, dizziness, sleep disturbance); GI effect (abdominal pain); Hypersensitivity reactions

• The deltoid region as a site for injection is recommended for adults and the anterolateral thigh for infants
• Injection in the gluteal region has been associated with diminished response

• Discomfort at injection site, redness, polyarthralgia with hand edema and rash

• Use with caution in pregnant and lactating women
• Monitor liver functions regularly
• Contraindicated in patients with hypersensitivity to thymosin alpha-1 and those immunosuppressed following transplantation