Details for: TARO-PEMETREXED
Company: TARO PHARMACEUTICALS INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02429195 | TARO-PEMETREXED | PEMETREXED (PEMETREXED DISODIUM) | 100 MG / VIAL | POWDER FOR SOLUTION | INTRAVENOUS |
| 02429209 | TARO-PEMETREXED | PEMETREXED (PEMETREXED DISODIUM) | 500 MG / VIAL | POWDER FOR SOLUTION | INTRAVENOUS |
| 02480492 | TARO-PEMETREXED | PEMETREXED (PEMETREXED DISODIUM) | 1000 MG / VIAL | POWDER FOR SOLUTION | INTRAVENOUS |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
TARO-PEMETREXED is used in the treatment of the following types of cancers:
- Malignant pleural mesothelioma (cancer of the lining of the chest cavity) in combination with cisplatin (another anticancer drug).
- Nonsquamous locally advanced or metastatic non-small cell lung cancer as:
- Initial treatment in combination with cisplatin.
- Maintenance treatment given alone immediately after four cycles of platinum-based first-line chemotherapy.
- Second line treatment given alone after prior chemotherapy.
What it does
TARO-PEMETREXED is an antifolate anticancer agent that works by disrupting the metabolic processes that are essential for cell replication. It helps to stop the cancer cells from multiplying.
When it should not be used
Do not take TARO-PEMETREXED if you:
- are allergic to pemetrexed disodium or any of the ingredients in TARO-PEMETREXED.
- have received or are going to receive the Yellow Fever vaccine.
What the medicinal ingredient is
TARO-PEMETREXED contains the active ingredient called pemetrexed disodium.
What the non-medicinal ingredients are
TARO-PEMETREXED contains mannitol. Hydrochloric acid and/or sodium hydroxide, may have been added to adjust pH.
What dosage form it comes in
TARO-PEMETREXED is supplied as sterile freeze-dried powder for intravenous infusion and is available in single-dose vials. Each vial contains either 100 mg, 500 mg, or 1,000 mg pemetrexed as pemetrexed disodium.
LATEX-FREE Stopper: Stopper is free from natural rubber or natural rubber latex.
Warnings and precautions
Serious Warnings and Precautions
- TARO-PEMETREXED should be administered under the supervision of a qualified physician experienced in the use of anticancer agents.
- Liver toxicity and rare cases of fatal liver failure have been reported in clinical trial patients treated with pemetrexed disodium alone or in combination with other anticancer drugs.
To lower your chances of side effects of TARO-PEMETREXED, you must also take folic acid and vitamin B12 injections prior to and during your treatment with TARO-PEMETREXED.
BEFORE you receive TARO-PEMETREXED talk to your doctor or pharmacist if:
- you have a severe hypersensitivity reaction to TARO-PEMETREXED or to any other ingredient used in the formulation.
- you are pregnant or planning to get pregnant (TARO-PEMETREXED may cause harm to an unborn child).
- you plan to father a child. (TARO-PEMETREXED may cause irreversible infertility).
- you are breast feeding.
- you are under 18 years old.
- you have a kidney disease.
- you have a liver disease.
- you have a heart problem.
- you have ever had radiation therapy.
- you have recently received or are planning on receiving a vaccine against Yellow Fever or any live vaccines.
You should discuss effective birth control methods with your doctor. Male patients should not father a child during the treatment and up to 6 months after stopping the treatment.
Interactions with this medication
Tell your doctor or pharmacist if you are taking or have taken other medications, including prescription and nonprescription medicines, vitamins, and natural health products.
Drugs that may interact with TARO-PEMETREXED include:
- NSAIDs (nonsteroidal anti-inflammatory drugs, e.g. ibuprofen): you should stop taking them for at least 5 days before, the day of, and at least 2 days after TARO-PEMETREXED treatment. If it is necessary to take NSAIDs inform your doctor and you will be monitored accordingly.
Proper use of this medication
Usual Dose
TARO-PEMETREXED is slowly infused (injected) into a vein. The injection or infusion will last about 10 minutes. You will usually receive TARO-PEMETREXED once every 21 days (3 weeks).
You may receive TARO-PEMETREXED alone or in combination with cisplatin, another anti-cancer agent. Your doctor will determine your treatment plan, be sure to ask your doctor or health care team if you have any questions.
If your doctor has prescribed cisplatin, it will be infused in your vein for about 2 hours starting about 30 minutes after your treatment with TARO-PEMETREXED.
Pre-Medications
To lower your chances of experiencing harmful side effects, it is important for you to take the following medication and vitamins prior to and/or during your treatment with TARO-PEMETREXED.
Corticosteroid
Your doctor will prescribe a medicine called a “corticosteroid” to take the day before, the day of, and the day after TARO-PEMETREXED treatment. Corticosteroid medicines lower your chances for getting skin reactions with TARO-PEMETREXED.
Folic Acid Tablets
You must start taking 350- 600 micrograms of folic acid every day for at least 5 days out of the 7 days before your first dose of TARO-PEMETREXED. You must keep taking folic acid every day during the time you are getting treatment with TARO-PEMETREXED and for 21 days after your last treatment.
You can get folic acid vitamins over-the-counter. Folic acid is also found in many multivitamin pills. Ask your doctor or pharmacist for help if you are not sure how to choose a folic acid product.
Vitamin B12 Injection
Your doctor will give you vitamin B12 injections while you are getting treatment with TARO-PEMETREXED. You will get your first vitamin B12 injection during the week before your first dose of TARO-PEMETREXED, and then about every 9 weeks during treatment until 3 weeks after the last dose of TARO-PEMETREXED.
Contact your doctor if you forget to take your pre-medications.
You will have regular blood tests before and during your treatment with TARO-PEMETREXED. Your doctor may adjust your dose of TARO-PEMETREXED or delay treatment based on the results of your blood tests and on your general condition.
Overdose
Missed Dose
Contact your physician immediately for further instructions.
Side effects and what to do about them
Most patients taking TARO-PEMETREXED will have side effects. Sometimes it is not possible to tell whether TARO-PEMETREXED, another medicine, or the cancer itself is causing these side effects. Call your doctor right away if you have a fever, chills, diarrhea, or mouth sores. These symptoms could mean you have an infection.
The most common side effects of TARO-PEMETREXED when taken alone or with cisplatin are:
- Stomach upset, including nausea, vomiting, diarrhea, and constipation.
- Low blood cell counts
- Low red blood cells may make you feel tired, get tired easily, appear pale, and become short of breath.
- Low white blood cells may give you a greater chance for infection. If you have a fever (temperature above 38°C) or other signs of infection, call your doctor right away.
- Low platelets give you a greater chance for bleeding. Your doctor will do blood tests to check your blood counts before and during treatment with TARO-PEMETREXED.
- Tiredness. You may feel tired or weak for a few days after your TARO-PEMETREXED treatments. If you have severe weakness or tiredness, call your doctor.
- Mouth, throat, or lip sores (stomatitis, pharyngitis). You may get redness or sores in your mouth, throat, or on your lips. These symptoms may happen a few days after TARO-PEMETREXED treatment. Talk with your doctor about proper mouth and throat care.
- Loss of appetite. You may lose your appetite and lose weight during your treatment.
- Kidney. Your kidney function may be decreased, sometimes seriously, which may make you feel unwell. Your doctor may do blood tests to monitor your kidney function.
- Rash. You may get a rash or itching during treatment. These usually appear between treatments with TARO-PEMETREXED and usually go away before the next treatment. Sometimes you may get severe skin reactions. Call your doctor if you get a severe rash or itching.
- Fever.
Effects on heart and brain have been reported uncommonly in clinical studies. Severe effects on stomach and intestine including bleeding has been uncommonly reported in clinical studies. Sometimes the effects on intestine are worse after radiation. In clinical studies, severe effects on lung and breathing have been reported. Blood flow disturbance leading to tissue damage has been reported.
Rare cases of unusual swelling in the legs or the face (edema) have been reported.
A small number of patients have reported changes in mood/ depression.
Be sure to tell your doctor if your breathing gets worse while you are on TARO-PEMETREXED.
Talk with your doctor, nurse, or pharmacist about any side effect that bothers you or that doesn't go away. It is important that you continue to take your folic acid and vitamin B12 supplements even if you experience serious side effects.
| Symptom / effect | Talk with your doctor or pharmacist Only if severe |
Talk with your doctor or pharmacist In all cases |
Stop taking drug and call your doctor or pharmacist* |
|---|---|---|---|
| Common | |||
| Allergic reaction | ✔ | ||
| Bleeding | ✔ | ||
| Breathing (Any change) | ✔ | ||
| Chest pain (new or worsening) | ✔ | ||
| Diarrhea | ✔ | ||
| Fever | ✔ | ||
| Mouth, throat or lip sores | ✔ | ||
| Nausea | ✔ | ||
| Skin rash | ✔ | ||
| Swallowing difficulty | ✔ | ||
| Tiredness | ✔ | ||
| Vomiting | ✔ | ||
*Continue taking your folic acid and vitamin B12 injections even if you have serious side effects. Common=1% to < 10%
This is not a complete list of side effects. For any unexpected effects while taking TARO-PEMETREXED, contact your doctor or pharmacist.
How to store
TARO-PEMETREXED (pemetrexed disodium) should be stored at room temperature 15°C to 30°C.
Once reconstituted, the solution can be stored for up to 24 hours when stored refrigerated, 2°C - 8°C. When prepared as directed, reconstituted and infusion solutions of TARO-PEMETREXED should be used immediately. Discard unused portion.
TARO-PEMETREXED is not light sensitive.
Reporting 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 at 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 Taro-Pemetrexed:
- 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.html); the manufacturer’s website www.taro.ca or by calling 1-800-268-1975.
This leaflet was prepared by:
Taro Pharmaceuticals Inc.
130 East Drive
Brampton, Ontario L6T 1C1
Last revised: August 30, 2018