Noxafil Side Effects

Generic Name: Posaconazole

Please note - some side effects for Noxafil may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Noxafil - for the consumer

Noxafil Suspension

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Noxafil Suspension:

Anxiety; constipation; coughing; diarrhea; dizziness; headache; muscle, joint, or back pain; nausea; sore throat; stomach pain or upset; tiredness; trouble sleeping.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain or tightness; dark urine; fast or irregular heartbeat; fever, chills, or persistent sore throat; loss of appetite; mouth inflammation; pale stools; severe or persistent headache or dizziness; severe or persistent nausea, vomiting, diarrhea, or stomach pain; severe or persistent tiredness or weakness; shortness of breath; swelling of the ankles, feet, or hands; tremor; unusual bruising or bleeding; vaginal bleeding; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

For the professional

Noxafil

The safety of posaconazole therapy has been assessed in 1844 patients.

This includes 605 patients in the prophylaxis studies, 796 in OPC/rOPC studies, and over 400 patients treated for other indications. Posaconazole therapy was given to 171 patients for ≥6 months, with 58 patients receiving posaconazole therapy for ≥12 months.

Prophylaxis of Aspergillus and Candida

TABLE 11 presents treatment-emergent adverse events observed at an incidence >10% in posaconazole prophylaxis studies.

TABLES 12 and 13 present treatment-related adverse events observed at an incidence ≥2% in posaconazole prophylaxis studies.

The most common treatment-related serious adverse events (1% each) in the combined prophylaxis studies were bilirubinemia, increased hepatic enzymes, hepatocellular damage, nausea, and vomiting.

In two randomized comparative studies in OPC, the safety of posaconazole at a dose of ≤ 400 mg QD in 557 HIV infected patients was compared to the safety of fluconazole in 262 HIV infected patients at a dose of 100 mg QD.

An additional 239 HIV infected patients with refractory OPC received posaconazole in 2 non-comparative trials for refractory OPC (rOPC). Of these subjects, 149 received the 800 mg/day dose and the remainder received the ≤400 mg QD dose.

TABLE 14 presents Treatment-Emergent Adverse Events of Clinical Significance in the comparative and non-comparative studies of OPC.

Treatment-related, treatment-emergent events observed in patients with OPC at an incidence of ≥2% are shown in TABLE 15.

Adverse events were reported more frequently in the pool of patients with refractory OPC. Among these highly immunocompromised patients with advanced HIV disease, serious adverse events (SAEs) were reported in 55% (132/239). The most commonly reported SAEs were fever (13%) and neutropenia (10%).

Treatment-related SAEs were reported for 14% (34/239) of these patients and included neutropenia (5%) and abdominal pain (2%). Posaconazole was discontinued in two patients who developed neutropenia that was considered serious and treatment-related. All other reported treatment-related SAEs occurred in ≤ 1% of subjects on posaconazole.

Uncommon and rare treatment-related serious or medically significant adverse events reported during clinical trials in prophylaxis, OPC/rOPC or other indications with posaconazole have included adrenal insufficiency, allergic and/or hypersensitivity reactions.

Rare cases of hemolytic uremic syndrome, thrombotic thrombocytopenic purpura, and pulmonary embolus have been reported primarily among patients who had been receiving concomitant cyclosporine or tacrolimus for management of transplant rejection or graft-vs-host disease.

During clinical development there was a single case of torsade de pointes in a patient taking posaconazole. This report involved a seriously ill patient with multiple confounding, potentially contributory risk factors, such as a history of palpitations, recent cardiotoxic chemotherapy, hypokalemia, and hypomagnesemia.

Additionally, in another indication, 428 patients were treated with ≥800 mg/day with a similar AE profile.

Clinical Laboratory Values

In healthy volunteers and patients, elevation of liver function test values did not appear to be associated with higher plasma concentrations of posaconazole. The majority of abnormal liver function tests were minor, transient, and did not lead to discontinuation of therapy.

For the prophylaxis studies, the number of patients with changes in liver function tests from Common Toxicity Criteria (CTC) Grade 0, 1, or 2 at baseline to Grade 3 or 4 during the study is presented in TABLE 16.

The number of patients treated for OPC with clinically significant liver function test (LFT) abnormalities at any time during the studies is provided in TABLE 17 (LFT abnormalities were present in some of these patients prior to initiation of the study drug).

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