Pemetrexed Disodium for Injection (Sandoz Canada): Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Pemetrexed disodium for Injection 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:

Pemetrexed Disodium for Injection 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 Pemetrexed Disodium for Injection if you:

• are allergic to pemetrexed disodium or any of the ingredients in Pemetrexed Disodium for Injection.
• have received or are going to receive the Yellow Fever vaccine.

What the medicinal ingredient is:

Pemetrexed Disodium for Injection contains the active ingredient called pemetrexed disodium hemipentahydrate.

What the nonmedicinal ingredients are:

Pemetrexed Disodium for Injection contains mannitol. Hydrochloric acid and/or sodium hydroxide may have been added to adjust pH.

What dosage forms it comes in:

Pemetrexed Disodium for Injection is supplied as sterile lyophilized powder for intravenous infusion and is available in single-dose vials. Each vial contains 100 mg, 500 mg, or 1000 mg pemetrexed as pemetrexed disodium hemipentahydrate.

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

• Pemetrexed Disodium for Injection 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 for Injection alone or in combination with other anticancer drugs.

To lower your chances of side effects of Pemetrexed Disodium for Injection, you must also take folic acid and vitamin B12 injections prior to and during your treatment with Pemetrexed Disodium for Injection.

BEFORE you receive Pemetrexed Disodium for Injection talk to your doctor or pharmacist

if:

• you have a severe hypersensitivity reaction to Pemetrexed Disodium for Injection or to any other ingredient used in the formulation.

• you are pregnant or planning to get pregnant (Pemetrexed Disodium for Injection may cause harm to an unborn child).

• you plan to father a child. (Pemetrexed Disodium for Injection 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 Pemetrexed Disodium for Injection 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 Pemetrexed disodium for Injection treatment. If it is necessary to take NSAIDs inform your doctor and you will be monitored accordingly.

PROPER USE OF THIS MEDICATION

Usual dose:

Pemetrexed Disodium for Injection is slowly infused (injected) into a vein. The injection or infusion will last about 10 minutes. You will usually receive Pemetrexed Disodium for Injection once every 21 days (3 weeks).

You may receive Pemetrexed Disodium for Injection 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 Pemetrexed Disodium for Injection.

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 Pemetrexed Disodium for Injection.

Corticosteroid

Your doctor will prescribe a medicine called a “corticosteroid” to take the day before, the day of, and the day after Pemetrexed Disodium for Injection treatment. Corticosteroid medicines lower your chances for getting skin reactions with Pemetrexed Disodium for Injection..

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 Pemetrexed Disodium for Injection. You must keep taking folic acid every day during the time you are getting treatment with Pemetrexed Disodium for Injection 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 Pemetrexed Disodium for Injection. You will get your first vitamin B₁₂ injection during the week before your first dose of Pemetrexed Disodium for Injection., and then about every 9 weeks during treatment until 3 weeks after the last dose of Pemetrexed Disodium for Injection..

Contact your doctor if you forget to take your pre-medications.

You will have regular blood tests before and during your treatment with Pemetrexed Disodium for Injection.. Your doctor may adjust your dose of Pemetrexed Disodium for Injection 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 Pemetrexed Disodium for Injection will have side effects. Sometimes it is not possible to tell whether Pemetrexed Disodium for Injection, 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 Pemetrexed Disodium for Injection 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 Pemetrexed Disodium for Injection.
• Tiredness. You may feel tired or weak for a few days after your Pemetrexed Disodium for Injection 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 Pemetrexed Disodium for Injection 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 Pemetrexed Disodium for Injection 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 Pemetrexed Disodium for Injection.

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.

*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 Pemetrexed Disodium for Injection, contact your doctor or pharmacist.

Pemetrexed Disodium for Injection powder should be stored at controlled room temperature 15°C -30°C. Reconstituted and infusion solutions prepared aseptically can be stored at refrigerated conditions (2-8°C) for up to 24 hours.

REPORTING SUSPECTED SIDE EFFECTS

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

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• Report online at www.healthcanada.gc.ca/medeffect
• Call toll-free at 1-866-234-2345

• Complete a Canada Vigilance Reporting Form and:

  • Fax toll-free to 1-866-678-6789, or

  • Mail to: Canada Vigilance Program

    Health Canada

    Postal Locator 0701E

    Ottawa, ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at www.healthcanada.gc.ca/medeffect

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals, can be obtained by contacting the sponsor, Sandoz Canada Inc., at:

1-800-361-3062

or by written request at:

145, Jules-Léger

Boucherville, (QC), Canada

J4B 7K8

or by e-mail at:

medinfo@sandoz.com

Last revised: May 4, 2016