Microsoft word - interferon-ribavirin_tmt_consent_2009.doc
Judy J. Davis, M.D., F.A.A.P. 7405 N. Fresno Street, Fresno, CA 93720 (559) 438-8400 FAX (559) 438-1174 INFORMED CONSENT FOR TREATMENT OF HEPATITIS C WITH INTERFERON AND RIBAVIRIN
Your medical provider has recommended treatment with Interferon and ribavirin for hepatitis C infection. These medications have been approved by the FDA for the treatment of hepatitis C. The goal of treatment is to clear the hepatitis C virus from your blood. This combination therapy has been proven to be effective in 30% to 60% of treated patients. Interferon is given by injection and you will be taught how to give yourself the injection. Ribavirin is a capsule that is taken orally. Your treatment may last up to 48 weeks. Most patients treated with Interferon and ribavirin experience side effects. Blood tests to monitor for side effects will be required every 2-4 weeks. Monthly follow-up appointments are mandatory. Side effects can include: 1 .
Injection site reaction, bruising, itching, irritation, inflammation.
Flu-like symptoms, fever, rigors, nausea, vomiting, muscle aches, fatigue, headache, chills, diarrhea.
Adverse psychiatric events including insomnia (sleeplessness), depression, suicidal behavior , suicidal attempts, completed suicides, psychosis, aggressive behavior, hallucinations, violent behavior, homicidal ideation in people with and without previous psychiatric disorder.
Anemia or low blood count which can exacerbate symptoms of coronary artery disease and deteriorate cardiac function.
Neutropenia or low white count which can increase the risk of other infections.
Thrombocytopenia (low platelet count) which can cause bleeding disorder.
Autoimmune disorders including hypothyroidism, thyroiditis, rheumatoid arthritis, systemic lupus erythematosus, psoriasis.
Pulmonary disorders (bronchoconstriction, dyspnea, pulmonary infiltrates, pneumonitis and pneumonia, and patient death).
Miscellaneous problems including high blood glucose, low blood pressure, irregular heartbeat, ulcerative and hemorrhagic colitis, visual changes, urticaria, angioedema, anaphylaxis, retinal hemorrhages and cotton wool spots.
THE FOLLOWING PATIENTS MAY HAVE SEVERE, LIFE-THREATENING SIDE EFFECTS: 1.
Patients with serious psychiatric illnesses such as depression. Alert your medical provider immediately if you develop depression or suicidal thoughts.
Patients with heart disease. If you experience any shortness of breath, palpitations, chest pain, notify your medical provider.
Renal failure patients. You should be closely monitored for signs and symptoms of Interferon toxicity. PEG-Intron could be used with caution in patients with creatinine clearances less than 50 ml/minute.
Rebetol/Intron-A therapy can cause severe birth defects if taken while pregnant and has been detected in sperm. It must not be used by women or male partners of women who are, or may become pregnant during therapy and up to six months after stopping therapy. Two forms of contraception should be used during treatment and for six months after treatment. If you, or your partner, become pregnant during treatment, notify your medical provider immediately.
I have read and understand the above; the risks and benefits were discussed with me and knowing the risk I agreed to treatment with Interferon and ribavirin. I agree to use at least two effective birth control methods. ___________________________________________________________
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