Guidelines

User Information

If you are using the Otrexup™ or Rasuvo® or Reditrex® injection at home:

The medicine comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

The medicine is given as a shot under your skin, usually on the stomach or thigh.

Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems from the injection.

If the medicine in the syringe has changed color, or if you see particles in it, do not use it.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For injection dosage form (solution):

For polyarticular juvenile idiopathic arthritis (pJIA):

Children—Dose is based on body size and must be determined by your doctor. The starting dose is 10 milligrams (mg) per meter squared (m2) once per week. Your doctor may adjust your dose as needed.

For psoriasis:

• Adults—At first, 10 to 25 milligrams (mg) once per week. Your doctor may adjust your dose as needed. However, the dose is usually not more than 30 mg once per week.
• Children—Use and dose must be determined by your doctor.
• For rheumatoid arthritis:
• Adults—At first, 7.5 milligrams (mg) once per week. Your doctor may adjust your dose as needed.
• Children—Use and dose must be determined by your doctor.

Missed Dose

This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.

Storage

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
• Keep out of the reach of children.
• Do not keep outdated medicine or medicine no longer needed.
• Ask your healthcare professional how you should dispose of any medicine you do not use.
• Put used syringe in a puncture-resistant disposable container.

Other Information – Mayo Clinic

Description and Brand Names

Drug information provided by: Merative, Micromedex®

US Brand Name

1. Otrexup
2. Rasuvo
3. RediTrex

Descriptions

Methotrexate injection is used alone or together with other medicines to treat several types of cancer, such as breast, head and neck, lung, blood, bone, lymph node, and uterus cancers.

Methotrexate belongs to the group of medicines known as antineoplastics (cancer medicines). It blocks an enzyme that is needed by cells to live. This interferes with the growth of cancer cells, which are eventually destroyed by the body. For patients with arthritis or psoriasis, methotrexate may work by improving the immune system.

This medicine is available only with your doctor’s prescription.

This product is available in the following dosage forms:

• Solution
• Powder for Solution

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of methotrexate injection for the treatment of cancer and juvenile idiopathic arthritis in children. However, safety and efficacy have not been established in children with psoriasis.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Otrexup™ or Reditrex® for the treatment of juvenile idiopathic arthritis in children. However, safety and efficacy have not been established in children with cancer and psoriasis.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of methotrexate injection in the elderly. However, elderly patients are more likely to have bone marrow, liver, or kidney problems, which may require caution and an adjustment in the dose in patients receiving methotrexate injection.

Breastfeeding

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Varicella Virus Vaccine, Live
• Zoster Vaccine, Live

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