Metoject Subcutaneous: Uses, Side Effects and Dosage

Serious Warnings and Precautions

What is METOJECT SUBCUTANEOUS used for?

METOJECT SUBCUTANEOUS is used to treat adults with the following severe disabling conditions when other treatments do not work:

• psoriasis (a skin disease).
• psoriatic arthritis (joint inflammation that affects people with psoriasis).
• rheumatoid arthritis (joint inflammation caused by the immune system).

How does METOJECT SUBCUTANEOUS work?

METOJECT SUBCUTANEOUS therapy helps control psoriasis and rheumatoid arthritis but it will not cure them. Some normal cells in the body may be affected as well.

Ask your healthcare professional if you have any questions about why it has been prescribed for you.

What are the ingredients in METOJECT SUBCUTANEOUS?

Medicinal ingredients: Methotrexate.

Non-medicinal ingredients: Sodium chloride, sodium hydroxide and water for injection.

METOJECT SUBCUTANEOUS comes in the following dosage forms:

• METOJECT SUBCUTANEOUS (methotrexate injection) 50 mg/mL (as methotrexate sodium) is available in single-use pre-filled syringes.
• METOJECT SUBCUTANEOUS is available in 8 doses that are colour-coded as follows:

• All syringes are available in cartons of 1, 4, or 12 single-use pre-filled syringes with embedded injection needles.
• The carton and the finger-grip on the syringe are colour-coded to match.

Do not use METOJECT SUBCUTANEOUS if you:

• Are allergic to methotrexate or any ingredient of the drug or container
• Have severe kidney problems, including kidney failure or kidney stones.
• Are on dialysis

• Are pregnant or plan on getting pregnant

• Are breast-feeding

• Suffer from alcoholism, alcoholic liver disease or other liver problems (including hepatitis B or C).

• Have immune system problems (immunodeficiency diseases)
• Have blood or bone marrow problems
• Are going to receive a general anesthetic called nitrous oxide. It is also known as laughing gas.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you

take METOJECT SUBCUTANEOUS. Talk about any health conditions or problems you may have, including if you:

• Have problems with fluid build-up in your body.

• Have any blood or bone marrow problems including:

  • Low levels of blood cells called platelets (thrombocytopenia).
  • Low red blood cells (anemia).
  • Low levels of white blood cells (neutropenia, leukopenia)
• Have inflamed blood vessels.
• Have cancer or tumours.
• Have an infection.
• Were recently vaccinated.
• Are dehydrated or have a lot of vomiting, diarrhea, or sweating.
• Are obese.
• Have diabetes .
• Have stomach ulcers.
• Have inflammatory bowel disease (ulcerative colitis).
• Have mouth sores or inflammation.
• Have a history of gout (a type of arthritis).
• Have or had a recent exposure to chicken pox or shingles.
• Been treated with radiation.

Other warnings you should know about:

METOJECT SUBCUTANEOUS can cause:

• Blood and bone marrow problems and can cause infections and affect your blood clotting. To reduce the risk of infection or bleeding, you should:

  • Avoid people with infections. Check with your healthcare professional right away if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or hard urination.
  • Check with your healthcare professional right away if you notice any abnormal bleeding or bruising; black, tarry stools; blood in urine or stools; or red spots on your skin.
  • Be careful when using a regular toothbrush, dental floss, or toothpick. Check with your healthcare professional before having any dental work done.
  • Do not touch your eyes or the inside of your nose unless you have just washed your hands.
  • Be careful not to cut yourself when you are using sharp objects such as scissors or a razor.
  • Avoid contact sports or other situations where bruising or injury can happen.
• Kidney problems. Your healthcare professional may want you to drink extra fluids so that you will pass more urine. This will help prevent kidney problems and keep your kidneys working well.

METOJECT SUBCUTANEOUS can also cause gastrointestinal, liver, lung, nervous system and skin problems. See the “Serious side effects and what to do about them” table, below, for more information on these and other serious side effects.

Immune system and vaccines:

• METOJECT SUBCUTANEOUS can affect your immune system. It can prevent your body from making antibodies that help avoid infections.
• METOJECT SUBCUTANEOUS can make diseases such as shingles or tuberculosis come back.
• Vaccines might not be effective during treatment. Rare infections related to vaccines can occur. You should not get any vaccines during treatment with METOJECT SUBCUTANEOUS.
• Avoid anyone who has had oral polio vaccine for at least six weeks. Do not get close to them or stay in the same room for very long. If this is not possible, wear a mask over your nose and mouth.

Female fertility: METOJECT SUBCUTANEOUS can cause abnormal periods and other vaginal bleeding problems for a short time during and after treatment. It can also affect your eggs.

Male fertility: METOJECT SUBCUTANEOUS can lower sperm count for a short time during and after treatment.

Children (less than 18 years old): METOJECT SUBCUTANEOUS is not for use in children.

Elderly (65 years or older): Side effects may happen more often. Your healthcare professional will monitor your health during and after treatment.

Check-ups and testing: You will have regular visits with your healthcare professional, before, during and at the end of your treatment. They will do blood tests to check your liver and kidney health, liver biopsies, lung tests and/or chest x-rays.

Driving and using machines: METOJECT SUBCUTANEOUS can cause fatigue and dizziness. Before you drive or do tasks that require special attention, wait until you know how you respond to METOJECT SUBCUTANEOUS.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with METOJECT SUBCUTANEOUS:

• Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) such as acetylsalicyclic acid (ASA, Aspirin)
• Leflunomide, used to treat rheumatoid arthritis or Disease Modifying Antirheumatic Drugs (DMARDs), such as gold, penicillamine, hydroxychloroquine, or sulfasalazine
• Medicines used to treat bacterial and fungal infections (such as antibiotics and amphotericin B), or to prevent malaria (such as pyrimethamine)
• Medicines used to treat leukemia, such as cytarabine and mercaptopurine
• Medicines used to treat stomach problems (proton pump inhibitors (PPI)) such as omeprazole, esomeprazole, and pantoprazole.
• Immunosuppressants such as azathioprine, cyclosporin
• Probenicid, used to treat gout
• Retinoid medicines, used to treat acne
• Sulfonylureas, used to treat diabetes
• Theophylline, used to treat respiratory diseases
• Vitamins such as folic acid and folinic acid
• Phenytoin, used to treat seizures
• Amiodarone, used to treat irregular heart beat
• Triamterene, used as a diuretic or “water pill”
• Packed red blood cells, used for blood transfusions.
• Radiotherapy, a type of cancer treatment
• Psoralen Plus Ultraviolet Light (PUVA) therapy, used to treat skin conditions

Tell any healthcare professional that is treating you that you are taking METOJECT SUBCUTANEOUS.

How to take METOJECT SUBCUTANEOUS:

• Always use METOJECT SUBCUTANEOUS exactly as your healthcare professional has shown you.
• Read the “INSTRUCTIONS FOR USE FOR METOJECT SUBCUTANEOUS SELF-INJECTION” section every time before you inject METOJECT SUBCUTANEOUS. Check with your healthcare professional if you are not sure.
• Do not take more or less of it, and do not take it more often than your healthcare professional has told you.
• METOJECT SUBCUTANEOUS is injected under the skin once a week.

• At the start of your treatment, METOJECT SUBCUTANEOUS will be injected by your healthcare professional.

  • Your healthcare professional might train you or your caregiver on how to inject METOJECT SUBCUTANEOUS under the skin.
  • Do not try to inject METOJECT SUBCUTANEOUS until you or your caregiver have received proper training.
  • Ask your healthcare professional any questions you may have.
• Pregnant or breast-feeding healthcare professionals or caregivers should not handle and/or inject METOJECT SUBCUTANEOUS.
• Each METOJECT SUBCUTANEOUS syringe can be used once. It must be thrown away after use in a sharps container.

Usual dose:

• The dose of METOJECT SUBCUTANEOUS will be different for different patients.
• The dose depends on what the medicine is being used for, your weight, and if you are taking other medicines.

• Your healthcare professional may lower your dose, stop your treatment for a period of time or recommend that you stop treatment completely. This may happen if you:

  • experience serious side effects, or
  • your disease gets worse.

Overdose:

If you think you, or a person you are caring for, have taken too much METOJECT SUBCUTANEOUS, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.

Missed Dose:

• If you missed a dose of METOJECT SUBCUTANEOUS, the next dose should be taken as soon as possible.
• Ask your healthcare professional if you have questions about missed doses.

What are the possible side effects from using METOJECT SUBCUTANEOUS?

These are not all the possible side effects you may have when taking METOJECT SUBCUTANEOUS. If you experience any side effects not listed here, tell your healthcare professional.

METOJECT SUBCUTANEOUS might cause other unwanted effects that may not occur until months or years after it is used. These delayed effects may include certain types of cancer, such as leukemia. Discuss these possible effects with your healthcare professional.

• Tiredness, weakness or dizziness
• Chills and fever
• Headaches
• Hair loss
• Ringing in the ears
• Mood changes, fits, confusion
• Nervous system problems: abnormal reflexes, paralysis, difficulty speaking, loss of consciousness, disorientation, reduced senses of touch or temperature, numbness or feelings of prickling (pins and needles)
• Sore eyes, short term blindness
• Inflamed gums

• Stomach/abdominal pain, indigestion, loss of appetite

  • Change in voice (hoarseness)
  • Skin rashes, pin-point red spots on the skin, reddening or whitening of the skin, acne, boils,
  • Lower sex drive, decreased fertility
  • Abnormal vaginal bleeding, missed periods, vaginal discharge
  • Injection Site Reactions: blistering, itching, pain, redness, severe skin damage, tenderness, build up of pus and fat, warmth in the area around the injection
  • Swelling in areas of the body that do not involve the injection sites.
  • Thin, fragile bones, muscle and joint pain
  • Diabetes

METOJECT SUBCUTANEOUS causes nausea and vomiting. Even if you begin to feel ill, do not stop using this medicine without first checking with your healthcare professional.

Methotrexate can cause abnormal blood and urine test results. Your healthcare professional will do these tests before, during and after treatment. These will tell your healthcare professional how METOJECT CUTANEOUS is affecting your blood, liver and kidneys are working.

Serious side effects and what to do about them

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

Storage:

• Store METOJECT SUBCUTANEOUS between 15 to 25°C in original carton. Store away from heat and light. Avoid freezing.
• Keep out of the reach and sight of children.
• Do not keep outdated medicine or medicine no longer needed. Throw away any unused solution.
• Properly discard of this medicine in a sharps container when it is expired or no longer needed. Talk to your pharmacist if you have any questions.

If you want more information about METOJECT SUBCUTANEOUS:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication 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.medexus.com), or by calling 1-877-MEDEXUS.

Medexus Pharmaceuticals Inc.

Last Revised: SEP 10, 2024

INSTRUCTIONS FOR USE FOR METOJECT SUBCUTANEOUS SELF-INJECTION:

Follow these instructions with all doses of METOJECT SUBCUTANEOUS. Check the packaging to make sure that you have the right syringe. It should match the dose your doctor has told you to take.

IMPORTANT: Methotrexate should not come into contact with the surface of the skin or mucous membranes. If this happens, rinse the area right away with plenty of water.

The parts of the METOJECT SUBCUTANEOUS pre-filled syringe are shown below (see Figure A)

Figure A

Note: The finger grip on your METOJECT SUBCUTANEOUS pre-filled syringe may be a different colour than shown in the Figures Use. See above section “What dosage forms it comes in:” for more information on colour-coding.

Figure B Ask your pharmacist about where you can get a sharps container. If you do not have a sharps container, you may use a household container that: is made of heavy-duty plastic or metal, can be closed with a tight-fitting, puncture-resistant lid, is upright and stable during use, is leak-resistant, and is properly labelled to warn of hazardous waste. Using a marker, write “BIOHAZARD” on the container. An empty detergent bottle or coffee can may be used. Check the expiry date on the METOJECT SUBCUTANEOUS pre-filled syringe packaging. Do not use if the expiry date has passed. If expired, discard the syringe in a sharps container (see Step VI), and get a new one.
STEP II: INJECTION SITE PREPARATION
1. Choose an injection site (see Figure C). You may inject METOJECT SUBCUTANEOUS into your abdomen or thigh. A caregiver may give you the injection in the back of your upper arm. Abdomen: Maintain a distance of about 5 cm from the belly button (navel). Do not inject above the bottom rib. OR Thigh: Inject into the outer, upper side of your right or left thigh. Maintain a distance of about 5 cm from both your knee and your groin. OR Back of Upper Arm (administration by a caregiver only): Give the injection into the back of the upper arm, just below the shoulder.

Figure C Do not inject METOJECT SUBCUTANEOUS in any other areas of the body. Choose a different injection site each time you give yourself an injection (e.g. right thigh then left thigh). This may reduce the risk of developing irritation at the injection site. Do not inject METOJECT SUBCUTANEOUS where the skin hurts or is hard, tender, bruised, red, scarred or has stretch marks. If you have psoriasis, do not inject directly into any raised, thick, red or scaly skin patches or lesions. Always inject yourself while sitting or lying down, not standing up. 2. Clean the injection site: Clean the area of and around the injection site with soap and water or disinfectant (see Figure D). Allow the site to dry for at least 60 seconds. Do not fan or blow on the clean area. Do not touch this area before injection. Figure D
STEP III: PREPARE THE SYRINGE AND NEEDLE
1. Take the blister tray packaging containing the METOJECT SUBCUTANEOUS syringe out of the carton. Open the METOJECT SUBCUTANEOUS blister packaging:

Hold the packaging flat and lift the white paper in one corner. Slowly pull the sealed paper off (see Figure E). Figure E 2. Grasp the pre-filled syringe by the body and take it out of the packaging. Do not hold or touch the plunger at any time (see Figure F). Figure F 3. Check the syringe and solution: Check the syringe for visual defects or cracks. Do not use the syringe if damaged. If damaged, discard the syringe in a sharps container (see Step VI), and get a new syringe. Look at the solution through the viewing window on the syringe. The solution should be yellow-brown in colour and should be clear with no particles in it. Do not use the syringe if the solution is discoloured or cloudy, or if it contains visible particles. If discoloured or cloudy, or if it contains visible particles, discard the syringe in a sharps container (see Step VI), and get a new syringe. You may see air bubbles. This is normal. You do not need to remove these. The air bubbles ensure the full and exact dose is delivered. 4. Remove the needle cover: Holding the syringe by the body in 1 hand, face the needle away from you. Do not hold or touch the plunger at any time. With the other hand, carefully remove the needle cover by turning it and pulling it straight off (see Figure G).

Figure G Do not touch the needle or allow it to touch any surface. You may see a drop of liquid at the end of the needle. This is normal. Discard the needle cover in a sharps container right away (see Step VI). Never put the needle cover back on after removal. Once the cover is removed, use the syringe immediately.
STEP IV: INJECT METOJECT SUBCUTANEOUS
1. Hold the body of the syringe in 1 hand like a pencil or dart (see Figure H). 2. With your other hand, use your thumb and index finger to grasp and hold a fold of cleaned skin at the injection site. Using a quick and dart-like motion, insert the needle straight into the fold of skin at a 90-degree angle. Do not hold or push the plunger while inserting the needle into the skin (see Figure H). Figure H 3. Insert the needle all the way into the fold of skin. Slowly and steadily press down on the plunger with your thumb and inject all of the liquid under your skin (see Figure I). Push the plunger all the way down until it stops moving. Hold the skin securely until the injection is completed.

Figure I 4. Before you remove the needle, check that the syringe is completely empty. Pull the needle straight out.
STEP V: AFTER THE INJECTION
1. Discard the pre-filled syringe directly in a sharps container immediately after use (see Step VI). 2. Press a cotton ball or gauze pad on the injection site if you see any blood. Hold it for about 10 seconds (see Figure J). Do not rub the injection site because this will irritate the site. Figure J 3. Methotrexate should not come into contact with the surface of the skin or mucosa. If this happens, rinse immediately with plenty of water.
STEP VI: DISPOSAL OF USED SUPPLIES
1. Place the used METOJECT SUBCUTANEOUS pre-filled syringe in a sharps container immediately after use (see Figure K).

Figure K Do not throw away the used syringe in your household trash. Do not reuse the syringe. The syringe must be discarded after use. Be careful not to touch the needle. If you or someone around you is injured by the needle, contact your healthcare professional right away. Always keep the container out of the reach and sight of children. Do not throw away the sharps container in your household trash or recycle it. When the container is full, follow your healthcare professional’s instructions to dispose of it safely. 2. Place the used cotton balls, gauze and packaging in your household trash, unless you are told otherwise.