Jamp-Methotrexate: Uses, Side Effects and Dosage

What the medication is used for:

Jamp-Methotrexate belongs to a group of medicines known as antimetabolites. It is used in high doses to treat many types of cancers, including breast cancer, Non- Hodgkin's lymphoma and leukemia. At lower doses, it may also be used to treat psoriasis and rheumatoid arthritis.

What it does: Jamp-Methotrexate works by blocking an enzyme needed by body cells to live. This interferes with the growth of some cells, such as skin cells in psoriasis that are growing rapidly. In rheumatoid arthritis, Jamp-Methotrexate acts on the inflammatory cells that cause joint swelling. Jamp-Methotrexate therapy is used to control psoriasis and rheumatoid arthritis but it will not cure them. In cancer, Jamp- Methotrexate works by blocking an enzyme process in cancer cells so that they cannot grow. Some normal cells in the body may be affected as well.

When it should not be used:

Do not take Jamp-Methotrexate if you:

• Are allergic to any component of the drug.
• Have severe kidney problems.
• Are on dialysis.

• Are pregnant. Jamp-Methotrexate can cause

  harm to your unborn baby. Women of childbearing potential should not be started on Jamp-Methotrexate until pregnancy is excluded.

• Are breast-feeding.

• Have psoriasis or rheumatoid arthritis and the

  following:

• alcoholism (drink excessive alcohol)

• chronic liver disease

• immunodeficiency (resistance to infectious

  diseases is reduced)

  • blood disorders
  • Are going to receive a general anesthetic called nitrous oxide. It is also known as laughing gas.

What the medicinal ingredient is:

Methotrexate (meth-o-TREX-ate).

What the important nonmedicinal ingredients are: Hydrochloric acid, sodium chloride, sodium hydroxide and water for injection.

What dosage forms it comes in:

Jamp-Methotrexate in the following presentations:

25 mg/mL

50 mg / 2 mL (no preservative) as a single use vial 2 mL vials with brown flip-off aluminum seals

1000 mg / 40 mL (no preservatives) as a single use vial 40 mL vials golden yellow flip-off aluminum seals

Before you use Jamp-Methotrexate, talk to your doctor or pharmacist if you have any of the following conditions:

• have or have had any unusual or allergic reaction to Jamp-Methotrexate.

• are pregnant or planning to become pregnant.

  Methotrexate can cause birth defects (deformed babies) or death of an unborn baby. Both male and female patients must use effective birth control methods all the time while taking Jamp-Methotrexate and a few months after the last dose of the drug. Methotrexate may cause sterility (infertility), which could be permanent. Be sure to discuss this with your doctor before taking Jamp-Methotrexate. Tell your doctor right away if you think you have become pregnant while taking Jamp-Methotrexate.

• Are breast-feeding or plan to breast-feed.

  Methotrexate may cause serious side effects. WARNINGS AND PRECAUTIONS

ABOUT THIS MEDICATION

Serious Warnings and Precautions

Jamp-Methotrexate should be prescribed by a doctor who is experienced with the use of antimetabolite therapy.

• Jamp-Methotrexate can cause serious toxic reactions which may result in death.
• Jamp-Methotrexate can cause birth defect (deformed babies) or death of an unborn baby when used in pregnant women. Pregnant women with psoriasis or rheumatoid arthritis should not take Jamp-Methotrexate.

Do not breastfeed while you are taking the drug

• have kidney problems
• have kidney disease

• are dehydrated or have a lot of vomiting,

  diarrhea, or sweating

• have or have had liver problems, including

  hepatitis B or hepatitis C infection

• have lung problems

• have problem with your immune system, or

  infections

  • have gastrointestinal problems such as

    vomiting, diarrhea, mouth sores or inflammation, ulcer, or colitis (ulcer of the intestines)

  • have a skin disease
  • have aneurologic disorder
  • drink alcohol

Jamp-Methotrexate increases sensitivity to sunlight. Avoid sun exposure and do not use sunlamp while taking this drug.

Methotrexate can cause sudden bleeding in the lungs. This is called Pulmonary alveolar haemorrhage. If you suddenly spit or cough up blood you must go to the hospital right away. You will need emergency care. This occurs in patients with some existing health problems. Some examples are rheumatic disorder (such as pain in your joints) or vasculitis such as swelling in an artery or vein.

Precautions While Using This Medicine

• Do not take Jamp-Methotrexate daily or more than

  the dose prescribed. Methotrexate can cause serious toxic reactions which may result in death.

• Do not drink alcohol.

• Do not drive a car or operate machinery until you

  know how Jamp-Methotrexate affects you since the drug may cause dizziness and fatigue.

• Drink extra fluid to prevent kidney problems.

• Have regular blood tests to reduce the risk of

  infection or bleeding. Methotrexate can lower the number of white blood cells and there is an increased risk of infection or bleeding.

  Talk to your doctor if you need a vaccination. Live vaccines may cause severe infections. Live vaccines or contact with any individual who has had a live vaccination should be avoided, since your ability to fight an infection (immune system) is decreased while taking Jamp-Methotrexate.

INTERACTIONS WITH THIS MEDICATION

Talk to your healthcare professional about all the medicines you take or have recently taken, including any drugs, vitamins, minerals, natural supplements or alternative medicines. Jamp- Methotrexate may interact with the following drugs:

• Non-steroidal anti-inflammatory drugs (NSAIDs)

  and acetyl salicyclate (acetylsalicyclic acid or (ASA) and other pain killers

• Disease Modifying Antirheumatic drugs

  (DMARDs), such as gold, penicillamine, hydroxychloroquine, or sulfasalazine

• Drugs that may cause harm to the liver

  (leflunomide, azathioprine, sulfasalazine, retinoid)

• Phenylbutazone.
• Phenytoin (to treat seizures)
• Probenecid
• Amphotericine B (may cause harm to kidneys)

• Certain antibiotics such as penicillins,

  tetracycline, vancomycin, nystatin, neomycin, trimethoprim/ sulfamethoxazole, ciprofloxacin, pristinamycin, chloramphenicol

• Theophylline
• Mercaptopurine
• Folic acid or folinic acid
• Cytarabine and other chemotherapy agents
• Radiotherapy
• L-asparagine, a drug used to treat cancer.
• Proton pump inhibitors (PPI), They are drugs used to treat acid-related stomach problems.Some PPIs are omeprazole,esomeprazole ,and pantoprazole.
• Pyrimethamine, an anti-parasitic drug
• Nitrous oxide, an inhaled gas used to prevent pain during medical procedures.
• Amiodarone, a drug used to treat abnormal heart rhythms
• Sulfonylureas, drugs used to lower blood sugar levels, aminobenzoic acid, sulfonamides, also known as “sulfa drugs”

• Packed red blood cells, used for blood

  transfusions

• PUVA therapy, a type of ultraviolet light

  treatment for severe skin conditions

• Triamterene, a drug used to reduce blood

  pressure and decrease swelling

  Do not take JAMP-METHOTREXATE if you are going to receive a general anesthetic called nitrous oxide. It is also known as laughing gas. When used together, they can cause

  • Myelosuppression (a condition in which the bone marrow cannot make enough blood cells),
  • Mouth sores,
  • Inflammation of the mouth,
  • Inflammation of the kidneys
  • Damage to the nervous system.

PROPER USE OF THIS MEDICATION

Jamp-Methotrexate Injection is for single-use only. Any unused product should be discarded by trained personnel.

Take Jamp-Methotrexate o n l y as directed by your doctor. Do not take more or less of it, and do not take it more often than your doctor ordered. The exact amount of medicine you need has been carefully worked out. Taking too much may increase the chance of side effects, while taking too little may not improve your condition. You should check with your doctor if you are not certain how to take the medication.

• In most cases, Jamp-Methotrexate i s taken once weekly; the prescribed dose is taken on a single day of the week.

• In some cases, your healthcare professional may

  instruct you to take Jamp-Methotrexate e v e r y 12 hours for 3 doses; you should only do this once a week, and should not take more than 3 doses each week.

• It should never be taken every day of the week

  When used to treat psoriasis or rheumatoid arthritis. As well, in most cases of cancer, Jamp-Methotrexate should not be taken every day of the week.

• Taking Jamp-Methotrexate daily, or in a dose

  larger than prescribed can result in serious complications, often requiring hospitalization, and sometimes resulting in death. Taking even small doses of Jamp-Methotrexate daily for less than a week can result in serious consequences, including death.

• Select a day of the week when you are most likely

  to remember to take Jamp-Methotrexate and take it on that same day each week.

• Each time you refill your prescription, check to

  see whether the dose you need to take has changed.

  Jamp-Methotrexate is often given together with certain other medicines. If you are using a combination of medicines, make sure that you take each one at the proper time and do not mix them. Ask your doctor or pharmacist to help you plan a way to remember to take your medicines at the right times.

  While you are using Jamp-Methotrexate, your doctor may want you to drink extra fluids so that you will pass more urine. This will help the drug to pass from the body, and will prevent kidney problems and keep your kidneys working well.

  If you vomit shortly after taking a dose of Jamp- Methotrexate, check with your doctor. You will be

  told whether to take the dose again or to wait until the next scheduled dose.

Usual dose:

The dose of Jamp-Methotrexate will be different for different patients. The dose that is used may depend on a number of things, including what the medicine is being used for, the patient's size, whether the medicine is being given by mouth or by injection, and whether or not other medicines are also being taken. If you are taking or receiving Jamp-Methotrexate at home, follow your doctor's orders or the directions on the label. If you have any questions about the proper dose of Jamp- Methotrexate, ask your doctor.

The doctor may decrease your dose if you have problems with your kidneys.

Overdose:

• Do this even if you have no signs of discomfort.

Missed dose:

• If you missed a scheduled dose, contact your doctor for instruction

Along with their needed effects, medicines like Jamp- Methotrexate can sometimes cause unwanted effects. Also, because of the way these medicines act on the body, there is a chance that they might cause other unwanted effects that may not occur until months or years after the medicine is used. These delayed effects may include certain types of cancer, such as leukemia. Discuss these possible effects with your doctor.

Jamp- Methotrexate commonly causes nausea and vomiting. Even if you begin to feel ill, do not stop using this medicine without first checking with your doctor. Ask your doctor for ways to lessen these effects.

The most common side effects include:

• Upset stomach, stomach pain, vomiting, nausea, loss of appetite, dizziness, chills and fever, diarrhea or sores on lips or mouth.

• A fall in the number of white blood cells.

  This may reduce your resistance to infection and increase your chance of cold sores, blood poisoning or swelling of blood vessels.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

For management of a suspected drug overdose, contact your regional Poison Control Centre immediately

• Tiredness (fatigue)

Less common side effects are:

• Headaches, hair loss, mood changes, confusion, ringing in the ears, sore eyes, skin rashes, increased sensitivity to sunlight or unexplained weight loss.
• A fall in the number of other blood cells. This may increase your chances of bruising, bleeding or tiredness.
• Damage to the lungs.
• Harm to the unborn baby.
• Convulsions

Rarely, Jamp-Methotrexate can cause other side effects including:

• Liver damage, kidney damage, pain or difficulty urinating, lower back or side pain, blood in urine or stools, dark urine
• Drowsiness, weakness
• Hoarseness
• Bloody vomit, black tarry stools or pin-point red spots on the skin

• Reddening or whitening of the skin, acne,

  boils, itching yellow skin or eyes

• Impotence or loss of interest in sex,

  decreased fertility, abortion

• Diabetes, thinning of the bones, painful muscles and joints
• Low blood pressure
• Gastrointestinal ulcers

More rarely, it can cause:

• Skin rash and other skin disorders.
• Cancer of lymph glands, sudden death

• Severe allergic reactions

  • Leukoencephalopathy
  • Damage to heart

This is not a complete list of side effects. For any unexpected effects while taking Jamp-Methotrexate , contact your doctor or pharmacist.

To store this medicine:

• Keep out of the reach of children.
• Store it between 15°C to 25°C and away from heat.

• Protect from light. Avoid freezing Jamp-

  Methotrexate

• Jamp-Methotrexate should not be used beyond the labeled expiry date.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

MORE INFORMATION

This document plus the full product monograph prepared for health professionals can be found by contacting Jamp Pharma Corporation at 1-866-399-9091

Jamp Pharma Corporation

1310 rue Nobel

Boucherville, Québec

Canada J4B 5H3

Date of Revision: September 25, 2019

HOW TO STORE IT

Reporting Side Effects

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.