warnings

What is the most important information I should know about Rasuvo (Subcutaneous)?

You should not use methotrexate if you are allergic to it. Methotrexate should not be used to treat psoriasis or rheumatoid arthritis if you have:

alcoholism, cirrhosis, or chronic liver disease;
low blood cell counts, o a weak immune system or bone marrow disorder; or
if you are pregnant or breastfeeding.

Methotrexate is sometimes used to treat cancer in people who have a condition listed above. Your doctor will decide if this treatment is right for you.

Tell your doctor if you have ever had:

kidney disease;
breathing problems;
a stomach ulcer or ulcerative colitis;
any type of infection; or
radiation treatment.

Methotrexate is sometimes used to treat cancer during pregnancy. However, methotrexate may cause injury or death to an unborn baby and should not be used during pregnancy to treat arthritis or psoriasis. Tell your doctor if you are pregnant.

Methotrexate can harm an unborn baby if the mother or the father is using this medicine.

If you are a woman, you may need a pregnancy test before starting this treatment. Use effective birth control to prevent pregnancy while you are using methotrexate and for at least 6 months after your last dose.
If you are a man, use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 3 months after your last dose.
Tell your doctor right away if a pregnancy occurs while either the mother or the father is using methotrexate.

This medicine may affect fertility (ability to have children) in both men and women. However, it is important to use birth control to prevent pregnancy because methotrexate may harm the baby if a pregnancy does occur.

Do not breastfeed while using this medicine, and for at least 1 week after your last dose.

Do not give this medicine to a child without medical advice.

Side Effects

What are the side effects of Rasuvo (Subcutaneous)?

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Methotrexate can cause serious or fatal side effects. Call your doctor at once if you have:

sudden chest pain, wheezing, dry cough, cough with mucus, feeling short of breath;
swollen lymph glands, night sweats, weight loss;
blisters or ulcers in your mouth, red or swollen gums, trouble swallowing;
vomiting, diarrhea, blood in your urine or stools;
skin changes such as redness, warmth, swelling, or oozing;
signs of metabolic acidosis--confusion, vomiting, lack of energy, irregular heartbeats;
low blood cell counts--fever, chills, bruising or bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath;
kidney problems--little or no urination, swelling in your feet or ankles;
liver problems--swelling around your midsection, right-sided upper stomach pain, nausea, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes);
nerve problems--confusion, weakness, drowsiness, coordination problems, feeling irritable, headache, neck stiffness, vision problems, loss of movement in any part of your body, seizure; or
signs of tumor cell breakdown--tiredness, muscle cramps, nausea, vomiting, diarrhea, fast or slow heart rate, tingling in your hands and feet or around your mouth.

Common side effects may include:

low blood cell counts, fever, chills, tiredness, not feeling well;
headache, dizziness, cough, chest tightness, trouble breathing;
mouth sores, nausea, vomiting, stomach pain, indigestion, diarrhea;
abnormal liver function tests;
runny or stuffy nose, sore throat; or
rash, hair loss, burning skin lesions, being more sensitive to light.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Interactions

What drugs and food should I avoid while taking Rasuvo (Subcutaneous)?

Avoid exposure to sunlight or artificial UV rays (sunlamps, tanning beds, or PUVA treatment), especially if you have psoriasis. Methotrexate can make your skin more sensitive to sunlight and your psoriasis may worsen.

Avoid drinking alcohol. It may increase your risk of liver damage.

Do not receive a "live" vaccine while using methotrexate, or you could develop a serious infection. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Methotrexate may impair your thinking or reactions. Avoid driving or operating machinery until you know how this medicine will affect you.

Dosage Guidelines & Tips

How to take Rasuvo (Subcutaneous)?

Use Rasuvo (Subcutaneous) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Methotrexate is usually given once per week. You must use the correct dose. Some people have died after incorrectly using methotrexate every day.

Methotrexate is injected into a muscle, under the skin, or as an infusion into a vein. A healthcare provider will give you this injection and may teach you how to properly use the medication by yourself.

Methotrexate may also be injected by a healthcare provider directly into a joint, or into the space around your spinal cord.

Read and carefully follow any Instructions for Use provided with your medicine. You may need to mix methotrexate with a liquid (diluent) before using it. Ask your doctor or pharmacist if you don't understand all instructions.

Prepare an injection only when you are ready to give it. Do not use if the medicine looks cloudy, has changed colors, or has particles in it. Call your pharmacist for new medicine.

Methotrexate can be toxic to your organs, and may lower your blood cell counts. You will need frequent medical tests, and you may need an occasional liver biopsy or chest X-ray.

If you develop a new (secondary) cancer during treatment with methotrexate injection, your healthcare provider will stop this medicine, and provide treatment if the new cancer does not go away after methotrexate injection is stopped.

If you need to be sedated for dental work, tell your dentist you currently use methotrexate.

Follow all storage instructions provided with your injectable medication. Your healthcare provider can provide more information about how to store this medicine.

A single-use vial (bottle) or auto-injector is for one use only. Use a needle and syringe only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

What should I do if I missed a dose of Rasuvo (Subcutaneous)?

Call your doctor for instructions if you miss an appointment for your methotrexate injection, or if you forget to use the medicine at home.