Tivdak 40 mg intravenous solution

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Medication name

Generic name:
Tisotumab vedotin - injection

Pronunciation
(tye-SOT-ue-mab ve-DOE-tin)

Brand name(s)
Tivdak

Warning

Tisotumab vedotin may cause serious eye problems. You should have regular eye exams before and during treatment with this medication. Follow your doctor's instructions carefully on what eye drops to use before and after your infusion of this medication. Do not wear contact lenses while you are on treatment with this medication unless directed by the doctor. Tell your doctor right away if you have signs of eye problems, including dry eyes, eye pain/redness/irritation, or blurred/decreased vision. Ask your doctor or pharmacist for more details.

Uses

This medication is used to treat cervical cancer. It works by slowing or stopping the growth of cancer cells.

How to use

See also Warning section.

Read the Medication Guide provided by your pharmacist before you start receiving tisotumab vedotin and each time you get an injection. If you have any questions, ask your doctor or pharmacist.

This medication is given by injection into a vein by a health care professional as directed by your doctor, usually once every 3 weeks. The medication is given over 30 minutes.

The dosage is based on your medical condition, weight, and response to treatment.

Use this medication regularly to get the most benefit from it. It may help to mark your calendar when to receive each dose.

Side effects

See also Warning section.

Nosebleeds, constipation, diarrhea, nausea, vomiting, loss of appetite, stomach/abdominal pain, weight loss, tiredness, or muscle/joint pain may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Temporary hair loss may occur. Normal hair growth should return after treatment has ended.

People using this medication may have serious side effects. However, you have been prescribed this drug because your doctor has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

Tell your doctor right away if you have any serious side effects, including:

  • easy bruising/bleeding
  • signs of infection (such as chills, fever, swollen lymph nodes)
  • sores/ulcers in the mouth/nose/genital area
  • bloody urine
  • unusual vaginal bleeding
  • black/tarry stools
  • numbness/tingling of arms/legs
  • muscle weakness

Get medical help right away if you have any very serious side effects, including:

  • signs of lung problems (such as cough that doesn't go away, chest pain, shortness of breath)
  • weakness on one side of the body
  • confusion

Tisotumab vedotin can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Get medical help right away if you develop any rash.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

  • rash
  • itching/swelling (especially of the face/tongue/throat)
  • severe dizziness
  • trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before receiving tisotumab vedotin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

  • liver disease
  • eye problems
  • nerve problems (such as numbness/tingling)
  • bleeding problems

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug.

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using tisotumab vedotin. Tisotumab vedotin may harm an unborn baby. Your doctor should order a pregnancy test before you start this medication. Women using this medication should ask about reliable forms of birth control during treatment and for 2 months after the last dose. Men using this medication should ask about reliable forms of birth control during treatment and for 4 months after the last dose. If you or your partner becomes pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this drug and for 3 weeks after the last dose. Consult your doctor before breastfeeding.

Drug interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Notes

Do not share this medication with others.

Lab and/or medical tests (such as complete blood counts, eye exams, kidney/liver function, blood mineral levels) should be done before you start receiving this medication and while you are receiving it. Keep all medical and lab appointments.

Missed dose

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

Storage

Not applicable. This medication is given in a hospital or clinic or doctor's office and will not be stored at home.

Important note

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Information last revised May 2024.

Selected from NATIONAL DRUG DATA FILE (NDDF) data included with permission and copyrighted by First Databank, Inc., 2019. This copyrighted material has been downloaded from a licensed data provider.

The above information is intended to supplement, not substitute for, the expertise and judgment of your health care professional. You should consult your health care professional before taking any drug, changing your diet, or commencing or discontinuing any course of treatment.