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Erivedge (Generic Vismodegib)

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WARNING

Every patient:

Women who are pregnant or who may become pregnant shouldn’t use vismodegib. There is a chance that vismodegib will result in miscarriage or the infant having birth abnormalities (physical issues that are present at birth).

Whenever you need a prescription refill for vismodegib, your doctor or chemist will provide you the manufacturer’s patient information leaflet (Medication Guide). If you have any questions, carefully read the information and ask your doctor or chemist. To obtain the Medication Guide, you can also go to the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer’s website.

While taking vismodegib and for 7 months after finishing therapy, avoid giving blood.

Do not give vismodegib to anyone else, not even if they exhibit the same symptoms as you.

Discuss the potential risks of taking vismodegib with your doctor.

Patients who are female:

If you are capable of getting pregnant, you must refrain from doing so while receiving treatment with vismodegib. A pregnancy test must come back negative within a week of the commencement of your medication. Throughout your treatment and for seven months following it, you must utilise an authorised method of birth control. You’ll learn which birth control methods are permitted from your doctor.

Call your doctor right away if you believe you are pregnant, miss a period, or engage in sexual activity without using birth control while taking vismodegib or within seven months after finishing your treatment.

Patients who are men:

Throughout the duration of your treatment with vismodegib and for three months after, you must use a condom each time you have intercourse with a woman who is pregnant or capable of getting pregnant. Even if you have a vasectomy, which is a procedure to stop sperm from leaving your body and creating conception, you still need to do this. If you have ever engaged in unprotected sexual activity with a woman who is capable of becoming pregnant or if you have any cause to suspect that your partner is pregnant, you should tell your doctor right away.

Don’t give away your sperm while you’re on vismodegib and for three months afterward.

Why is this medication prescribed?

When cancer has spread to other body parts, vismodegib is used to treat basal cell carcinoma, a form of skin cancer. Basal cell carcinoma that is resistant to radiation or surgery or that has returned after surgery is also treated with vismodegib. Hedgehog pathway inhibitors are a group of drugs that includes vismodegib. It functions by preventing the action of a protein that instructs cancer cells to proliferate. This may also help decrease tumours by slowing or halting the spread of cancer cells.

How should this medicine be used?

Vismodegib is available as a capsule to be swallowed. Typically, it is taken once day, with or without food. Take vismodegib at around the same time each day to make it easier for you to remember to take it. Ask your doctor or chemist to explain any instructions on your prescription label that you are unsure about following. Follow the prescription for vismodegib strictly. Never take it in larger or less amounts or more frequently than directed by your doctor.

Do not break, chew, or crush the capsules; instead, swallow them whole.

Other uses for this medicine

Ask your doctor or chemist for more details if you believe this drug should be used for something else.

What special precautions should I follow?

Before taking vismodegib,

  • If you have any allergies, including to vismodegib, other drugs, or any of the substances in vismodegib capsules, notify your doctor right away. For a list of the ingredients, consult the Medication Guide or speak with your chemist.
  • Inform your physician and chemist about all prescription and over-the-counter drugs, vitamins, dietary supplements, and herbal products you are now taking or intend to use. Be certain to bring up any of the following: antacids; specific antibiotics including erythromycin (E.E.S., Eryc, Ery-Tab, Erythrocin, PCE), azithromycin (Z-Pak, Zithromax), and clarithromycin (Biaxin, in Prevpac); a digestive aid such as ranitidine (Zantac), famotidine (Pepcid), or cimetidine (Tagamet) that treats heartburn, ulcers, or indigestion; and proton-pump inhibitors including pantoprazole (Protonix), rabeprazole (AcipHex), lansoprazole (Prevacid, in Prevpac), omeprazole (Prilosec), and dexlansoprazole (Dexilant). Your physician might need to adjust the dosage of your drugs or keep a close eye on you for side effects. Vismodegib may interact with a wide range of other drugs, so be sure to let your doctor know about everything you’re taking, even anything not on this list.
  • While using vismodegib and for seven months following treatment, avoid breast-feeding.

What special dietary instructions should I follow?

Keep eating normally unless your doctor instructs you otherwise.

What should I do if I forget a dose?

Ignore the missed dose and carry on with my normal dosing routine. To make up for a missing dose, do not take a second one.

What side effects can this medication cause?

Vismodegib could have negative effects. If any of these symptoms are severe or do not go away, let your doctor know right once:

  • Muscles cramping
  • Joints hurt
  • Tiredness
  • Hair fall
  • Alteration in flavour or loss of flavour
  • Reduction in appetite
  • Slim down
  • Nausea
  • Vomiting
  • Diarrhea
  • Constipation
  • Missing menstrual cycles

Vismodegib may have other negative effects. If you experience any strange issues while taking this medicine, contact your doctor right away.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online at http://www.fda.gov/Safety/MedWatch or by phone at 1-800-332-1088 if you have a serious side event.

What should I know about storage and disposal of this medication?

Keep this medication tightly closed in the original container and out of the reach of children. Keep it at room temperature and out of the bathroom and other places with excessive heat and moisture.

Unused prescriptions must be disposed of carefully to prevent pets, kids, and other people from ingesting them. You should not, however, dispose of this medication in the toilet. Instead, utilizing a medicine take-back program is the easiest approach to get rid of your medication. To find out about take-back programs in your area, speak with your chemist or the garbage/recycling agency in your city. If you do not have access to a take-back program, see the FDA’s Safe Disposal of Medicines website at http://goo.gl/c4Rm4p for additional information.

As many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and are simple for young children to open, it is crucial to keep all medications out of sight and out of reach of children. Always lock safety caps and promptly stash medication up and away from young children where it is out of their sight and reach to prevent poisoning. http://www.upandaway.org

In case of emergency/overdose

Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Additionally, information can be found online at https://www.poisonhelp.org/help. Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.

What other information should I know?

Keep all of your doctor’s appointments.

Any queries you may have regarding prescription refills should be directed to your chemist.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.

Brand names

  • Erivedge®
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