Trabectedin

By Medically reviewed by hellodoktor

Generic Name: Trabectedin Brand Name(s): Generics only. No brands available. Avability: Rx Pregnancy Category: N

Uses

What is Trabectedin used for?

Trabectedin is used to treat certain types of cancer. It is a chemotherapy drug that works by slowing the growth of cancer cells.

How should I take Trabectedin?

This medication is given by injection into a large vein (central line) by a health care professional. It is usually given every 3 weeks.

Your doctor will order a corticosteroid (such as dexamethasone) to lower the risk of liver problems or prevent side effects such as nausea/vomiting. These medications are usually given at least 30 minutes before your dose of trabectedin.

The dosage is based on your height, weight, medical condition, lab test results, and response to treatment.

How do I store Trabectedin?

Drug vials should be stored in a refrigerator at 2 to 8 degrees Celsius (36 to 46 Fahrenheit). Any unused portion of the reconstituted product or of the infusion solution should be discarded 30 hours after administration. Drug vials with particles or discoloration should be discarded.

There may be different brands of Trabectedin that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Trabectedin down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Trabectedin?

Before receiving trabectedin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain other 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: low blood cell counts, liver disease (such as active hepatitis), kidney disease, recent/current infections.

This drug may make you feel tired or weak. Alcohol or marijuana can make you more tired. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Alcohol can increase the risk of liver problems. Talk to your doctor if you are using marijuana. .

Trabectedin can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

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).

This medication may damage sperm in men. For both men and women using this medication, trabectedin may decrease the ability to have children in the future. Consult your doctor for more details.

This medication must not be used during pregnancy. It may harm an unborn baby. If you become pregnant or think you may be pregnant, or if your partner becomes pregnant, tell your doctor right away. To avoid pregnancy, both men and women receiving this drug should use reliable form(s) of birth control (such as birth control pills, condoms) during treatment, and for 3 months after treatment for women, and for 5 months after treatment for men. Consult your doctor for details and to discuss effective forms of birth control.

It is unknown if this drug passes into breast milk. Do not breast-feed while using this drug and for 3 months after treatment.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Trabectedin during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Trabectedin. Trabectedin is pregnancy risk category N according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Trabectedin?

Headache, weakness, tiredness, constipation, diarrhea, body aches, skin darkening, or trouble sleeping may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Nausea and vomiting can also occur and may be severe. Tell your doctor right away if these effects occur. In some cases, your doctor may prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals, not eating before treatment, or limiting activity may help to lessen the nausea and vomiting.

Many people using this medication develop serious side effects. However, your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

Trabectedin may cause serious injury at the injection site. Tell your health care professional right away if you experience pain, irritation, redness, or swelling at the injection site. Prompt treatment will help reduce discomfort and possible skin damage.

Trabectedin decreases bone marrow function, an effect that may lead to a low number of blood cells such as red cells, white cells, and platelets. Your doctor will monitor you closely and check your blood often during treatment. You may also receive another medication to reduce the risk of this side effect. If your blood cell count is too low, you should not receive trabectedin. Tell your doctor right away if you develop any of the following symptoms: unusual tiredness, pale skin, signs of infection (such as fever, chills, persistent sore throat), easy bruising/bleeding.

This medication may cause liver problems. Alcohol can increase the risk of liver problems. Do not drink alcoholic beverages. Your doctor will order blood tests to check for liver problems. Tell your doctor right away if you notice any of the following serious side effects: yellowing eyes/skin, dark urine, severe stomach/abdominal pain, persistent nausea/vomiting.

This drug may rarely cause serious muscle problems (rhabdomyolysis). Tell your doctor right away if you develop any of these symptoms: muscle pain/tenderness/weakness, signs of kidney problems (such as change in the amount of urine).

This medication may rarely cause a blood clot in the lungs (pulmonary embolism) or serious heart problems. Get medical help right away if you have: chest pain, trouble breathing, coughing up blood, swelling ankles/feet, sudden unexplained weight gain, severe tiredness, fast heartbeat.

This medication may rarely cause a serious condition (capillary leak syndrome), that can sometimes be fatal. Get medical help right away if you develop symptoms, including: sudden swelling, shortness of breath, signs of kidney problems (such as passing less urine), severe dizziness.

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.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Trabectedin?

Some products that may interact with this drug include: “statins” (such as atorvastatin, simvastatin).

Other medications can affect the removal of trabectedin from your body, thereby affecting how trabectedin works. These drugs include azole antifungals (such as fluconazole, ketoconazole), macrolide antibiotics (such as clarithromycin), HIV drugs (such as ritonavir), rifamycins (such as rifabutin), St. John’s wort, and some drugs used to treat seizures (such as carbamazepine, phenobarbital, primidone), among others.

Trabectedin may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Trabectedin?

Trabectedin may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

Avoid grapefruit, grapefruit juice, and alcohol during treatment.

What health conditions may interact with Trabectedin?

Trabectedin may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Trabectedin.

What is the dose of Trabectedin for an adult?

Usual Adult Dose for Soft Tissue Sarcoma

-Normal Bilirubin and AST or ALT 2.5 Times the Upper Limit of Normal (ULN) or Less:

1.5 mg/m2 via IV infusion every 21 days (3 weeks)

-Serum Bilirubin Levels Above Institutional ULN:

No recommended dose.

Duration of Therapy: Until disease progression or unacceptable toxicity

Comments:

-Administer this drug over 24 hours through a central venous line using an infusion set with a 0.2 micron polyethersulfone (PES) in-line filter.

-Complete infusion within 30 hours of drug reconstitution.

-Administer dexamethasone 20 mg IV 30 minutes prior to each dose.

Use: Treatment of patients with unresectable or metastatic liposarcoma or leiomyosarcoma who received a prior anthracycline-containing regimen.

Renal Dose Adjustments

-Mild (CrCl 60 to 89 mL/min) or Moderate (CrCl 30 to 59 mL/min) Renal Impairment: No adjustment recommended.

Liver Dose Adjustments

SEVERE LIVER DYSFUNCTION (Bilirubin 2 x ULN and AST or ALT 3 x ULN with Alkaline Phosphatase Less than 2 x ULN) in the prior treatment cycle: Permanently discontinue treatment.

FOR ELEVATED ALT, AST, ALKALINE PHOSPHATASE, or TOTAL BILIRUBIN:

-First Dose Reduction: 1.2 mg/m2 every 3 weeks

-Second Dose Reduction: 1.0 mg/m2 every 3 weeks

-Once reduced, the dose should not be increased in subsequent treatment cycles.

ALT or AST:

-More than 2.5 x ULN: Delay next dose for up to 3 weeks.

-More than 5 x ULN: Reduce next dose by one dose level.

Alkaline Phosphatase:

-More than 2.5 x ULN: Delay next dose for up to 3 weeks and reduce next dose by one dose level.

Total Bilirubin:

-Greater than the ULN: Delay next dose for up to 3 weeks and reduce next dose by one dose level.

PERMANENTLY DISCONTINUE TREATMENT FOR:

-Persistent adverse reactions requiring a dosing delay of more than 3 weeks.

-Adverse reactions requiring dose reduction following administration of this drug at 1.0 mg/m2.

Dose Adjustments

Strong CYP450 3A Inhibitors (including grapefruit products):

-Avoid concomitant use.

-If necessary to use strong CYP450 3A inhibitor for less than 14 days, administer the CYP450 inhibitor 1 week after infusion of this drug and discontinue the inhibitor the day prior to the next infusion of this drug.

Strong CYP450 3A Inducers (including St. John’s Wort):

-Avoid concomitant use.

FOR THE FOLLOWING ADVERSE REACTIONS:

-First Dose Reduction: 1.2 mg/m2 every 3 weeks

-Second Dose Reduction: 1.0 mg/m2 every 3 weeks

-Once reduced, the dose should not be increased in subsequent treatment cycles.

PLATELETS:

-Less than 100,000 platelets/microliter: Delay next dose for up to 3 weeks.

-Less than 25,000 platelets/microliter: Reduce next dose by one dose level.

ABSOLUTE NEUTROPHIL COUNT:

-Less than 1,500 neutrophils/microliter: Delay next dose for up to 3 weeks

-Less than 1,000 neutrophils/microliter with fever/infection: Reduce next dose by one dose level.

-Less than 500 neutrophils/microliter lasting more than 5 days: Reduce next dose by one dose level.

CREATINE PHOSPHOKINASE:

-More than 2.5 x ULN: Delay next dose for up to 3 weeks.

-More than 5 x ULN: Reduce next dose by one dose level.

DECREASED LEFT VENTRICULAR EJECTION FRACTION:

-Less than lower limit of normal (LLN) OR Clinical evidence of cardiomyopathy: Delay next dose for up to 3 weeks.

-Absolute decrease of 10% or more from baseline and less than LLN OR Clinical evidence of cardiomyopathy: Reduce next dose by one dose level.

OTHER NON-HEMATOLOGIC ADVERSE REACTIONS:

-Grade 3 or 4: Delay next dose for up to 3 weeks and reduce next dose by one dose level.

PERMANENTLY DISCONTINUE TREATMENT FOR:

-Persistent adverse reactions requiring a dosing delay of more than 3 weeks

-Adverse reactions requiring dose reduction following drug administration at 1.0 mg/m2

What is the dose of Trabectedin for a child?

The dosage has not been established in pediatric patients. It may be unsafe for your child. It is always important to fully understand the safety of the drug before using. Please consult with your doctor or pharmacist for more information.

How is Trabectedin available?

Trabectedin is available in the following dosage forms and strengths:

  • Intravenous powder for injection.

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Trabectedin, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

Hello Health Group does not provide medical advice, diagnosis or treatment.

Review Date: August 9, 2018 | Last Modified: September 12, 2019

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