Patient Medication Information: uses, side effects, how to take - Nat-Trabectedin
ABOUT THIS MEDICATION
What the medication is used for:
NAT-TRABECTEDIN (trabectedin) is used for the treatment of patients with metastatic liposarcoma or leiomyosarcoma
(forms of soft tissue sarcoma) when previous medicines
have been unsuccessful. NAT-TRABECTEDIN has been shown to slow growth of liposarcoma or leiomyosarcoma but it is not
known if NAT-TRABECTEDIN prolongs overall survival or
improves quality of life of patients with these sarcomas.
NAT-TRABECTEDIN in combination with PLD (pegylated liposomal doxorubicin hydrochloride) (another anti-cancer medicine) is used for the treatment of patients with
platinum-sensitive ovarian cancer after one previous therapy. NAT-TRABECTEDIN has been shown to slow growth of
ovarian cancer but it is not known if NAT-TRABECTEDIN prolongs overall survival or improves quality of life of patients with ovarian cancer.
What it does:
NAT-TRABECTEDIN is an anticancer medicine that works by preventing the tumour cells from multiplying.
When it should not be used:
If you are allergic (hypersensitive) to trabectedin or to
any ingredient in the formulation or component of the
container of NAT-TRABECTEDIN.
- If you are breast-feeding.
- If you have an active serious or uncontrolled infection.
What the medicinal ingredient is:
trabectedin
What the nonmedicinal ingredients are:
phosphoric acid, potassium dihydrogen phosphate,
potassium hydroxide, sucrose.
What dosage forms it comes in:
NAT-TRABECTEDIN is a powder for injection. The powder is reconstituted in sterile water and further diluted in a sterile
salt solution or sugar solution before it is infused.
NAT-TRABECTEDIN is available in a vial that contains 1 mg
trabectedin.
WARNINGS AND PRECAUTIONS
Serious Warnings and Precautions
NAT-TRABECTEDIN should be prescribed and managed only by a doctor experienced in anticancer drugs.
In order to avoid irritation at the site of injection,
NAT-TRABECTEDIN must be given to you through a central venous line.
NAT-TRABECTEDIN or its combination with PLD must not be used if you have increased blood bilirubin levels.
Serious side effects which have been reported with the use of NAT-TRABECTEDIN include:
- Increase in liver enzymes which can be monitored by lab tests
- Severe muscle pain or weakness (rhabdomyolysis)
Decrease in white blood cells which may lead to
infection
- Blood clots in the lung
- Severe reaction at site of injection
BEFORE you use NAT-TRABECTEDIN talk to your doctor or pharmacist if:
you have a history of myelosuppression (a decrease in
the production of blood cells);
- you have any problems with your kidneys;
- you have any problems with your liver;
you are pregnant, planning to become pregnant or
breast-feeding.
NAT-TRABECTEDIN is not recommended in children or adolescents under 18 years of age.
Contraception and Pregnancy:
Both men and women must use effective contraception while receiving NAT-TRABECTEDIN, and for 3 months after treatment for women and 5 months after treatment for men.
You must make sure that you do not become pregnant while receiving NAT-TRABECTEDIN, but if you do, inform your doctor immediately. NAT-TRABECTEDIN may harm your fetus. You should not take NAT-TRABECTEDIN if you are pregnant.
Genetic counselling is recommended for patients wishing to have children after therapy. Male patients should seek advice on sperm conservation prior to treatment because of the risk of irreversible infertility due to therapy with
NAT-TRABECTEDIN.
Breast-Feeding:
NAT-TRABECTEDIN must not be given to patients who are breastfeeding. Therefore you must stop breast-feeding before you start your treatment and you must not begin breast-feeding again until your doctor has confirmed that it is safe to do so.
Driving and using machines:
Tiredness and weakness have been reported in patients receiving NAT-TRABECTEDIN. Do not drive or operate any dangerous tools or machines if you experience such side
effects. Even if you have not felt these effects, you must
still be cautious.
INTERACTIONS WITH THIS MEDICATION
Inform your doctor, medical health personnel or pharmacist
about all medicines you are taking, whether prescribed for
you or bought without a prescription.
The following medications may lower the effect of
NAT-TRABECTEDIN:
- Rifampin for bacterial infection
- Phenobarbital for epilepsy
- St. John’s Wort, an herbal medicine for depression
The following medicines may increase the effect of
NAT-TRABECTEDIN:
- Ketoconazole for fungal infections
- Ritonavir for HIV infection
- Clarithomycin for bacterial infections
- Cyclosporine an immune-suppressive medicine
Verapamil for high blood pressure or heart
condition
The following medicines may increase risks of muscle or
liver damage (rhabdomyolysis):
- Statins for lowering cholesterol levels
Alcohol must be avoided during treatment with
NAT-TRABECTEDIN.
PROPER USE OF THIS MEDICATION
Usual dose:
The dose will be calculated from your height and weight.
For the treatment of metastatic liposarcoma or
leiomyosarcoma, the usual dose is 1.5 mg/m2 body surface
area as a 24-hour intravenous infusion.
For the treatment of ovarian cancer, the usual starting dose
is 1.1 mg/m2 body surface area as a 3-hour intravenous
infusion after PLD 30 mg/m2 body surface areas, as a
90-minute intravenous infusion.
The infusion is given every 3 weeks, although occasionally
your doctor may recommend dose delays to ensure that you
receive the most appropriate dosage of NAT-TRABECTEDIN.
You must be premedicated with corticosteroids such as
dexamethasone 20 mg IV, 30 minutes before each
NAT-TRABECTEDIN infusion; not only to prevent vomiting, but also because it appears to protect the liver. Before NAT-TRABECTEDIN is given to you, it is reconstituted and diluted and then put into a drip bag for intravenous use.
In order to avoid irritation at the site of injection, NAT-TRABECTEDIN be given to you through a central venous line.
During the treatment period, your doctor will carefully
monitor you and decide the most appropriate dosage of NAT-TRABECTEDIN to give you. The length of your whole treatment period will depend on your progress and how well you feel. Your doctor will tell you how long your treatment lasts.
Overdose:
For management of a suspected drug overdose, contact your regional poison control centre.
Missed dose:
If you think that you have missed a dose of NAT-TRABECTEDIN, tell your healthcare provider immediately.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Like all medicines, NAT-TRABECTEDIN or its combination with PLD can cause side effects, although not everyone gets them.
Side effects caused by NAT-TRABECTEDIN treatment:
Very common (may affect more than 1 in 10 people) side effects are that you may:
- feel tired
- feel shortness of breath
- bruise more easily
- have nose bleeds
have a decrease in white blood cells or platelets which
may lead to infection or unexpected bruising or bleeding
have blood infections (neutropenic infection and
neutropenic sepsis). Your doctor will order regular blood tests to detect any abnormalities in the blood.
- experience headache and a loss of strength
lose your appetite, feel sick (nausea) or vomit, and
become constipated. If you still feel sick, vomit or are unable to drink fluids and therefore pass less urine, despite being given anti-sickness medication, you should immediately seek medical help.
have diarrhea, loss of water from the body,
inflammation of the mouth (stomatitis), pain in the abdomen, weight loss, digestive discomfort and a change in your sense of taste
have the hand and foot syndrome. It may present as red
skin of the palms, fingers, and soles of the feet that later may become swollen and violaceous. The lesions may either dry out and desquamate, or blister with ulceration
increase in blood bilirubin levels which may lead to
yellow eyes or skin, dark urine
- lose hair (alopecia)
- low levels of potassium
- sleep disorder (insomnia)
pain, redness or swelling of the skin at the site of
injection
Your doctor may require blood tests in certain situations in order to avoid developing muscle damage to the muscles
(rhabdomyolysis). In very severe cases this could lead to kidney failure. If you experience severe muscle pain or
weakness, you should seek medical attention immediately.
Some other common (may affect up to 1 in 10 people) side
effects that you may have are:
- a higher skin pigmentation and rash
- coughing
- dizziness, low blood pressure and flushing
fever. If you have a raised temperature you should seek
medical attention immediately
mucosal inflammation as a swelling redness of the
inside of the mouth leading to painful ulcers and mouth
sores or as an inflammation of the gastrointestinal tract
- a syncope also called fainting
a weakness in the ventricles, the heart's major pumping
chambers (left ventricular dysfunction), sudden
blockage in a lung artery (pulmonary embolism) and an
abnormal build up of fluid in the lungs, which leads to
swelling (pulmonary oedema)
- pain in your back, muscles and joints
damage to your nerves which may result in tingling,
numbness, and burning sensation in the extremities
- general swelling or swelling of the limbs
In uncommon (may affect up to 1 in 100 people) cases you
may experience yellowing of your skin and eyeballs
(jaundice), pain in the upper right area of your abdomen,
nausea, vomiting, a general sense of not feeling well,
difficulty in concentrating, disorientation or confusion, and
sleepiness. These signs could mean that your liver is not
working properly. If you experience any of these symptoms
you should seek medical attention immediately.
If any of the side effects get serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor.
SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | |||
|---|---|---|---|
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist | |
| Only if severe | In all cases | ||
| Very Common (may affect more than 1 in 10 people) | |||
| Decrease in white blood cells or platelets in blood which may lead to infection or unexpected bruising or bleeding | √ | ||
| Nausea, vomiting | √ | ||
| Fatigue | √ | ||
| Loss of appetite | √ | ||
| Increase in blood bilirubin levels which may lead to yellow eyes or skin, dark urine | √ | ||
| Reddening painful skin on hands and feet | √ | ||
| Increase in blood creatine phosphokinase which may lead to muscle pain, weakness, muscle spasms | √ | ||
| Mouth ulceration, mucosal inflammation | √ | ||
| Common (may affect up to 1 in 10 people) | |||
| Fever | √ | ||
| Heart muscle problems, including heart failure that may be present as new chest pain, shortness of breath, tiredness, swelling in your legs, ankles or feet, or heart palpitations | √ | ||
| Rare (may affect up to 1 in 1000 people) | |||
Allergic reaction (hypersensitivity) that may present as fever, difficulty breathing, redness or flushing of the skin or a rash, feeling sick (nausea) or being sick (vomiting) | √ | ||
| Unknown | |||
| Capillary leak syndrome, the symptoms of which may include sudden swelling (edema) of the arms, legs and other parts of the body, occurring with or without sudden drop in blood pressure | √ | ||
This is not a complete list of side effects. For any unexpected effects while taking NAT-TRABECTEDIN, contact your doctor or pharmacist.
HOW TO STORE IT
NAT-TRABECTEDIN should be stored in the refrigerator
(2ºC – 8ºC).
The reconstituted solution should not be stored longer than
24 hours at 2ºC to 8ºC.
The total hold time between initial reconstitution and end of treatment should not be longer than 30 hours
REPORTING SUSPECTED SIDE EFFECTS
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free 1-866-234-2345
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
MORE INFORMATION
If you want more information about NAT-TRABECTEDIN:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer's website www.natcopharma.ca, or by calling 1-800-296-9329.
Natco Pharma (Canada) Inc. Mississauga, Ontario L5N 1P7