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About TRABECTEDIN

TRABECTEDIN belongs to a group of medicines known as 'anti-cancer' used to treat various cancers, including ovarian cancer and soft tissue sarcoma. Cancer is a condition where cells in a specific body part grow and reproduce uncontrollably. Breast cancer is cancer that forms in the cells of the breasts. A liposarcoma is a rare cancer that develops in your fatty tissue.

TRABECTEDIN contains Trabectedin, which works by sticking to the DNA in cells and damaging it. This stops the cancer cells from growing and multiplying.

TRABECTEDIN should be administered to patients only in a hospital setting under the supervision of a physician qualified by training and experience to administer cancer chemotherapeutic agents. The most common adverse reactions that occur while on therapy are anaemia, bruising, bleeding gums or nosebleeds, feeling or being sick, headaches, Constipation, diarrhoea, loss of appetite, liver changes, high levels of substances in the blood and increased risk of getting an infection, Symptoms include a change in temperature, aching muscles, headaches, feeling cold and shivery and generally unwell. Most of these side effects of TRABECTEDIN do not require medical attention and gradually resolve over time. However, if the side effects persist, contact your doctor.

To treat your condition effectually, continue taking TRABECTEDIN for as long as your doctor has prescribed. Do not stop using the TRABECTEDIN midway. It is expected to cause fetal harm when administered to a pregnant woman, so it should not be used in pregnant women. Both women and men using this TRABECTEDIN should use birth control to avoid pregnancy. Discontinue nursing while on therapy, considering the importance of the drug to the mother. Caution should be exercised while using TRABECTEDIN in patients with hepatic, renal, heart dysfunction and or Neutropenia (Lower-than-normal levels of neutrophils), so inform your doctor about all your medical conditions and medications you are currently taking.

Uses of TRABECTEDIN

Ovarian Cancer and Soft Tissue Sarcoma (Liposarcoma)

Medicinal Benefits

TRABECTEDIN contains Trabectedin, which belongs to a group of medicines known as 'anti-cancer' used to treat various types of cancers, including ovarian cancer and soft tissue sarcoma. It works by sticking to the DNA in cells and damaging it. This stops the cancer cells from growing and multiplying.

Directions for Use

TRABECTEDIN should be administered to patients only in a hospital setting under the supervision of a physician qualified by training and experience to administer cancer chemotherapeutic agents.

Storage

Store in a cool and dry place away from sunlight

Side Effects of TRABECTEDIN

  • Anaemia
  • Bruising, bleeding gums or nosebleeds
  • Feeling or being sick
  • Headaches
  • Tiredness
  • Dizziness
  • Constipation
  • Diarrhoea
  • Loss of appetite
  • Liver changes
  • High levels of substances in the blood
  • Increased risk of getting an infection
  • Change in temperature
  • Aching muscles
  • Headaches
  • Feeling cold and shivery
  • Generally unwell
  • Low levels of albumin
  • High levels of creatinine in your blood
  • Joint, back or muscle pain
  • Tummy (abdominal) pain
  • Fluid buildup (oedema)
  • Sore mouth
  • Breathlessness and coughing
  • Loss of appetite

In-Depth Precautions and Warning

Drug Warnings

Before taking the TRABECTEDIN, let your doctor know about all your allergic or hypersensitivity reactions to medicines or food. Before taking TRABECTEDIN, inform your doctor about your medical history and other medications you are currently taking in order to rule out any potential negative effects. TRABECTEDIN may cause permanent fertility problems in men if they take it. Please discuss this with their doctor before starting treatment. Women of childbearing age should use effective contraception during and up to 3 months after treatment with TRABECTEDIN. Avoid the consumption of alcoholic beverages and grapefruit juices.

Drug Interactions

Drug-Drug Interactions: TRABECTEDIN interacts with immunomodulatory medication (e.g. baricitinib, fingolimod), antifungal infections (e.g. ketoconazole), vaccinations (e.g. BCG Vaccine, mumps virus vaccine, rotavirus vaccine), and antipsychotic medications (e.g. Clozapine).

Drug-Food Interactions: Do not drink grapefruit juice or alcoholic beverages while you are being treated with TRABECTEDIN. It can affect the way the medicine works.

Drug-Disease Interactions: TRABECTEDIN may potentially interact with various disease conditions, including infections (bacterial/fungal/protozoal/viral) and severe hepatic and renal impairment.

Drug-Drug Interactions Checker List:

  • BARICITINIB
  • FINGOLIMOD
  • KETOCONAZOLE
  • BCG VACCINE
  • MUMPS VIRUS VACCINE
  • ROTAVIRUS VACCINE
  • CLOZAPINE
  • Safety Advice

    • Safety Warning

      Alcohol

      unsafe

      Avoid alcohol consumption while on treatment with TRABECTEDIN.

    • Safety Warning

      Pregnancy

      unsafe

      TRABECTEDIN should not be used during pregnancy because it can harm your fetus (newborn baby).

    • Safety Warning

      Breast Feeding

      unsafe

      Do not breastfeed during this treatment because the medicine may pass into your milk. Doctors normally advise against breastfeeding throughout this treatment and for a certain period of time after the final medication is taken.

    • Safety Warning

      Driving

      caution

      TRABECTEDIN may cause side effects such as tiredness and dizziness. Do not drive or use machines if you feel tired or dizzy.

    • Safety Warning

      Liver

      caution

      Caution should be exercised. Hepatotoxicity may occur. Monitor and delay and/or reduce dose if needed.

    • Safety Warning

      Kidney

      caution

      No dose adjustment is recommended in patients with mild [creatinine clearance (CLcr) 60-89 mL/min] or moderate (CLcr of 30-59 mL/min) renal impairment. There is no information available on patients with severe kidney impairment.

    • Safety Warning

      Children

      caution

      Talk to your care team about the use of this medication in children. Special care may be needed.

    Habit Forming

    No

    Diet & Lifestyle Advise

    • De-stress yourself by meditating, reading books, taking a warm bubble bath or listening to soothing music.
    • Performing yoga may also help in improving both physical and mental health.
    • Maintain a healthy weight by performing regular low-strain exercises and eating healthy food.
    • Eat a healthy diet and exercise regularly to maintain proper weight.
    • Include leafy vegetables, citrus fruits, fatty fish, berries, yoghurt, apples, peaches, cauliflower, cabbage, broccoli, beans, and herbs.
    • Get optimal sleep; rest well.
    • Avoid smoking and alcohol consumption.
    • Avoid fast food, fried food, processed meats, refined carbs and added sugars.

    Special Advise

    • Pregnancy testing is recommended for females of reproductive potential prior to initiating treatment with TRABECTEDIN.
    • TRABECTEDIN should be taken under strict medical supervision. The doctor will regularly monitor your condition while taking TRABECTEDIN.
    • Your doctor may get routine blood tests done to monitor your liver function, electrolyte levels, and blood cell count in your blood.
    • Peripheral blood counts should be frequently monitored during TRABECTEDIN treatment and, when appropriate, until recovery is achieved.
    • Do not donate sperm during treatment with TRABECTEDIN and for three months after your last dose.

    Patients Concern

    Disease/Condition Glossary

    Cancer: Cancer is a condition where cells in a specific body part grow and reproduce uncontrollably. The cancerous cells can invade and destroy surrounding healthy tissue, including organs. Cancer sometimes begins in one body part before spreading to other areas.

    Ovarian cancer: Ovarian cancer is a cancer that begins in the female reproductive organs where the ovaries/eggs are formed. It often has no symptoms in the early stages. Later stages are associated with symptoms such as weight loss and loss of appetite.

    Liposarcoma: Liposarcoma is a rare tumour derived from fat tissue that occurs in the “soft tissues” of the body (soft tissue sarcoma). It is classified as a cancer (malignant) because of its potential to recur locally and spread to other areas of the body. The severity of the disease depends on the subtype of the liposarcoma and the presenting stage of the primary tumour. It can arise in various locations throughout the body, although it is most frequently found in the extremities, particularly in the thigh.

    FAQs

    How does TRABECTEDIN work?

    TRABECTEDIN contains Trabectedin, which works by sticking to the DNA in cells and damaging it. This stops the cancer cells from growing and multiplying.

    Who should not receive TRABECTEDIN?

    It is recommended not to be used in the population who are allergic to Trabectedin or any other ingredients in this medication, is a pregnant woman, has too low blood cell counts, or suffers from severe liver or hepatic impairment.

    Does TRABECTEDIN cause Low White Blood Cell Count?

    Yes, TRABECTEDIN can cause low neutrophils levels, a type of white blood cells that help fight infections. Your doctor will monitor peripheral blood cell counts and adjust the dose as appropriate.

    Does TRABECTEDIN cause infertility in men?

    TRABECTEDIN may cause permanent fertility problems in men if they take it. Please discuss this with their doctor before starting treatment.

    Available Medicines for

    TRABECTEDIN