Trabectedin Injection (TRABECTEDIN - INJECTION)

Instructions

This medicine is given as an IV injection into a vein.

This medicine should be given by a trained health care provider.

You must be monitored by a health care professional during and after each dose is given.

If you miss a dose, contact your doctor for instructions.

Drug interactions can change how medicines work or increase risk for side effects. Tell your health care providers about all medicines taken. Include prescription and over-the-counter medicines, vitamins, and herbal medicines. Speak with your doctor or pharmacist before starting or stopping any medicine.

Tell your doctor if symptoms do not get better or if they get worse.

Your doctor may prescribe other medications to reduce side effects. Follow instructions carefully.

Keep using this medicine for the full number of days that it is prescribed. Do not stop the medicine even if you start to feel better.

Keep all appointments for medical exams and tests while on this medicine.

Cautions

Tell your doctor and pharmacist if you ever had an allergic reaction to a medicine.

Some patients on this medicine have developed severe, life-threatening infections. Please speak with your doctor about the risks and benefits of using this medicine.

This medicine is associated with a rare, but serious problem of the liver. Speak to your doctor about the early signs of liver problems and the benefits and risks of using this medicine.

This medicine is associated with an increased risk for serious blood clots. Speak with your doctor about the benefits and risks from using this medicine.

Your ability to stay alert or to react quickly may be impaired by this medicine. Do not drive or operate machinery until you know how this medicine will affect you.

Do not drink beverages with alcohol while on this medicine.

If you drink more than a few alcoholic beverages each day, ask your doctor whether you should be on this medicine.

Contact your doctor if you notice a change in the amount or darkening of your urine.

This medicine may reduce your body's ability to fight infections. Avoid contact with people with colds, flu or other infections. Contact your doctor if you develop fever, cough, sore throat, or chills.

Speak with your health care provider before receiving any vaccinations.

Tell the doctor or pharmacist if you are pregnant, planning to be pregnant, or breastfeeding.

Do not breastfeed while on this medicine. You may safely start breastfeeding 3 months after stopping treatment.

Do not use this medicine if you are pregnant. If you become pregnant, contact your doctor immediately.

This medicine can hurt a new baby in the womb. If you become pregnant while on this medicine, tell your doctor immediately. Your doctor may switch you to a different medicine.

This medicine may damage sperm. Men should use reliable birth control while taking this medicine.

Women of childbearing age should have a negative pregnancy test before starting this medicine.

Women must use reliable forms of birth control while taking this medicine and for 3 months after stopping to prevent pregnancy.

Men with a female partner who is of childbearing age must use reliable birth control during sexual activity while taking this medicine and for 5 months after stopping to prevent pregnancy.

Do not take St. John's wort while on this medicine.

Call your doctor right away if you notice any unusual bleeding or bruising.

Some patients have serious side effects from this medicine. Ask your pharmacist to show you the information from the Food and Drug Administration (FDA) and discuss it with you.

Side Effects

The following is a list of some common side effects from this medicine. Please speak with your doctor about what you should do if you experience these or other side effects.

• agitated feeling or trouble sleeping
• body aches
• constipation or diarrhea
• lack of energy and tiredness
• headaches
• darkening of skin or nails

Call your doctor or get medical help right away if you notice any of these more serious side effects:

• bleeding or bruising
• chest pain
• cough that does not go away
• swelling of the legs, feet, and hands
• fainting
• fever or chills
• fast or irregular heart beats
• pain, redness, swelling near injection
• pus at injection site
• signs of kidney damage (such as change in urine color or bubbly urine)
• signs of liver damage (such as yellowing of eye or skin, dark urine, or unusual tiredness)
• pale or blue skin, lips or fingernails
• shortness of breath
• sore throat
• severe or persistent vomiting
• sudden or unexplained weight gain

A few people may have an allergic reaction to this medicine. Symptoms can include difficulty breathing, skin rash, itching, swelling, or severe dizziness. If you notice any of these symptoms, seek medical help quickly.