What are the possible side effects of Novisof?
Get emergency medical help if you have any signs of an allergic reaction to Novisof: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or
fever, swollen gums, painful mouth sores, skin sores, cold or flu symptoms, cough.
Common Novisof side effects may include:
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.
Side effects of Novisof in details
A side effect of any drug can be defined as the unwanted or undesired effect produced by the drug. The side effect can be major or in few medications minor that can be ignored. Side effects not only vary from drug to drug, but it also depends on the dose of the drug, the individual sensitivity of the person, brand or company which manufactures it. If side effects overweigh the actual effect of the medicine, it may be difficult to convince the patient to take the drug. Few patients get specific side effects to specific drugs; in that case, a doctor replaces the drug with another. If you feel any side effect and it troubles you, do not forget to share with your healthcare practitioner.
Summary of the Safety Profile: During treatment with Novisof in combination with ribavirin or with peginterferon alfa and ribavirin, the most frequently reported adverse drug reactions were consistent with the expected safety profile of ribavirin and peginterferon alfa treatment, without increasing the frequency or severity of the expected adverse drug reactions.
Assessment of adverse reactions is based on pooled data from five Phase 3 clinical studies (both controlled and uncontrolled).
The proportion of subjects who permanently discontinued treatment due to adverse reactions was 1.4% for subjects receiving placebo, 0.5% for subjects receiving Novisof + ribavirin for 12 weeks, 0% for subjects receiving Novisof + ribavirin for 16 weeks, 11.1% for subjects receiving peginterferon alfa + ribavirin for 24 weeks and 2.4% for subjects receiving Novisof + peginterferon alfa + ribavirin for 12 weeks.
Tabulated Summary of Adverse Reactions: Novisof has mainly been studied in combination with ribavirin, with or without peginterferon alfa. In this context, no adverse drug reactions specific to Novisof have been identified. The most common adverse drug reactions occurring in subjects receiving Novisof and ribavirin or Novisof, ribavirin and peginterferon alfa were fatigue, headache, nausea and insomnia.
The following adverse drug reactions have been identified with Novisof in combination with ribavirin or in combination with peginterferon alfa and ribavirin. The adverse reactions are listed below by body system/organ class and frequency. Frequencies are defined as follows: Very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000) or very rare (<1/10,000).
Other Special Populations: Human Immunodeficiency Virus/Hepatitis C Virus (HIV/HCV) Co‑Infection: The safety profile of Novisof and ribavirin in HCV/HIV co‑infected subjects was similar to that observed in mono‑infected HCV subjects treated with Novisof and ribavirin in Phase 3 clinical studies.
Patients Awaiting Liver Transplantation: The safety profile of Novisof and ribavirin in HCV infected subjects prior to liver transplantation was similar to that observed in subjects treated with Novisof and ribavirin in Phase 3 clinical studies.
Description of Selected Adverse Reactions: Cardiac Arrhythmias: Cases of severe bradycardia and heart block have been observed when Novisof is used in combination with daclatasvir and concomitant amiodarone and/or other drugs that lower heart rate.
Reporting of Suspected Adverse Reactions: It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions.
What is the most important information I should know about Novisof?
- Novisof may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
- Novisof does not stop the spread of HCV to others through blood or sexual contact. Do not have any kind of sex without protection (eg, latex or polyurethane condoms) if you have HCV infection. Do not share needles, injection supplies, or items like toothbrushes or razors. Talk with your health care provider about ways to prevent the spread of HCV to others.
- Do not change your dose or stop taking Novisof or any of your medicines without checking with your doctor.
- When your medicine supply is low, get more from your doctor or pharmacist as soon as you can. Do not stop taking Novisof, even for a short period of time. If you do, the virus may grow resistant to the medicine and become harder to treat.
- Women who may become pregnant and men who use Novisof must use 2 effective nonhormonal forms of birth control while they take Novisof with ribavirin and for at least 6 months after treatment is stopped. Talk with your doctor if you have questions about effective birth control. If you or your sexual partner become pregnant while taking Novisof or within 6 months after you stop taking it, contact your doctor immediately.
- Women of childbearing potential who either take Novisof with ribavirin or are sexual partners of men who take Novisof with ribavirin must have a pregnancy test before treatment is started, monthly during treatment, and monthly for 6 months after treatment is stopped.
- Tell your doctor or dentist that you take Novisof before you receive any medical or dental care, emergency care, or surgery.
- Lab tests, including complete blood cell counts and HCV levels, may be performed while you use Novisof and for several months after you stop Novisof. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Novisof should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: Novisof must be used with ribavirin. Ribavirin use during pregnancy has resulted in birth defects and fetal death. If you are able to become pregnant, talk with your doctor or pharmacist about the use of effective birth control while using Novisof. If you become pregnant while taking Novisof or within 6 months after you stop taking it, contact your doctor immediately. You will need to discuss the benefits and risks of using Novisof while you are pregnant. It is not known if Novisof is found in breast milk. Do not breast-feed while taking Novisof.
Contraindication can be described as a special circumstance or a disease or a condition wherein you are not supposed to use the drug or undergo particular treatment as it can harm the patient; at times, it can be dangerous and life threatening as well. When a procedure should not be combined with other procedure or when a medicine cannot be taken with another medicine, it is called Relative contraindication. Contraindications should be taken seriously as they are based on the relative clinical experience of health care providers or from proven research findings.
When Novisof is used in combination with ribavirin or peginterferon-α/ribavirin, the contraindications applicable to those agents are applicable to combination therapies. Refer to the prescribing information of peginterferon-α and ribavirin for a list of their contraindications.
Novisof combination treatment with ribavirin or peginterferon-α/ribavirin is contraindicated in women who are pregnant or may become pregnant and men whose female partners are pregnant because of the risks for birth defects and fetal death associated with ribavirin.
The results of a survey conducted on ndrugs.com for Novisof are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Novisof. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.
Information checked by Dr. Sachin Kumar, MD Pharmacology