RediTrex (injection)

RediTrex is used together with other cancer treatments to treat acute lymphoblastic leukemia and osteosarcoma in both adults and children.

RediTrex can also be used alone or with other treatments to prevent and treat meningeal leukemia, and to treat non-Hodgkin lymphoma in adults and children.

RediTrex is used with other cancer treatments to treat gestational trophoblastic neoplasia and breast cancer in adults.

RediTrex is also used alone to treat squamous cell carcinoma of the head and neck in adults.

RediTrex is used to treat severe psoriasis and rheumatoid arthritis in adults, and to treat active polyarticular juvenile idiopathic arthritis in children.

RediTrex may also be used for reasons not mentioned in this medication guide.

RediTrex should not be used during pregnancy to treat arthritis or psoriasis. This injection is sometimes used to treat cancer during pregnancy. Inform your doctor if you are pregnant or intend to become pregnant.

RediTrex can cause serious or deadly side effects. Tell your doctor if you experience diarrhea, mouth sores, shortness of breath, upper stomach pain, dark urine, numbness or tingling, muscle weakness, confusion, seizures, or a skin rash that spreads and leads to blistering and peeling.

You should not use RediTrex if you are allergic to it.

RediTrex should not be used to treat psoriasis or arthritis if you have:

• alcoholism, cirrhosis, or liver disease;
• a blood cell disorder or a weak immune system; or
• if you are pregnant or breastfeeding.

RediTrex 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 (or if you are on dialysis);
• breathing problems, fluid build-up around the stomach (ascites), or a buildup of fluid around your lungs (also called pleural effusion);
• a stomach ulcer or ulcerative colitis;
• a history of neurologic problems such as seizures;
• any type of infection;
• radiation treatment;
• alcoholism; or
• if you plan to have any surgeries with general anesthesia, including dental surgery.

Make sure you are current on all vaccines before you start using RediTrex. Tell your doctor if you recently received a vaccine or are scheduled for a booster dose.

RediTrex can harm an unborn baby if the mother or father is using RediTrex. This medicine injection may affect fertility in men or women. Pregnancy could be harder to achieve while either parent is using this medicine. Tell your doctor if you are pregnant.

• If you are a woman, you may need a pregnancy test to confirm you are not pregnant. Use birth control while using this medicine and for at least 6 months after your last dose.
• If you are a man, use birth control if your sex partner is able to get pregnant. Keep using birth control for at least 3 months after your last dose.

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

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

RediTrex can cause serious or fatal side effects. Call your doctor immediately if you have:

• sudden chest pain, wheezing, dry cough, feeling short of breath;
• swollen lymph glands, night sweats, weight loss;
• blisters or sores in your mouth, red or swollen gums, trouble swallowing, feeling very thirsty;
• blood in your urine or stools, skin changes like redness, warmth, swelling, or oozing;
• unusual bruising or bleeding, new signs of infection (fever, weakness, cough, diarrhea, burning when you urinate);
• 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—swelling, urinating less, feeling tired or short of breath;
• liver problems—loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• nerve problems—confusion, weakness, drowsiness, coordination problems, feeling irritable, headache, neck stiffness, back pain, vision problems, loss of movement in any part of your body, seizure; or
• signs of tumor cell breakdown—tiredness, weakness, muscle cramps, nausea, vomiting, diarrhea, fast or slow heart rate, tingling in your hands and feet or around your mouth.

Common side effects of RediTrex may include:

• low blood cell counts, fever, chills, tiredness, feeling unwell;
• headache, dizziness, cough, chest tightness, trouble breathing;
• mouth sores, nausea, vomiting, stomach pain, diarrhea, runny or stuffy nose, sneezing, sore throat;
• abnormal liver function tests; or
• rash, hair loss, skin lesions, eyes 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.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

RediTrex is usually given once per week. Do not use this medicine more often than prescribed. Follow your doctor's dosing instructions very carefully.

Doses are based on body surface area (height and weight). Your dose may change if you gain or lose weight or if you are still growing.

RediTrex 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.

RediTrex is injected in the stomach or thigh when used for psoriasis or arthritis. Do not inject within 2 inches of your navel (belly button), arms or other areas of the body, or areas where the skin is tender, bruised, red, hard, or has scars or stretch marks.

Prepare an injection only when you are ready to give it. Call your pharmacist if the medicine looks cloudy, has changed colors or has particles in it.

Do not reuse a needle or syringe, especially a single-use vial (bottle) or auto-injector. Place them in a puncture-proof "sharps" container and dispose of it following state or local laws.

You will need frequent medical tests, and your next dose may be delayed based on the results.

Using RediTrex may increase your risk of developing other cancers. Ask your doctor about this risk.

Follow all storage instructions provided with RediTrex. Your pharmacist can provide more information about how to store this medicine.

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

Seek emergency medical help or call the Poison Help line at 1-800-222-1222. Taking too much methotrexate injection can be deadly.

RediTrex may make you more susceptible to sunburn. Stay out of direct sunlight or tanning beds. Wear protective clothing and apply sunscreen (SPF 30 or higher) when you go outside.

Do not drink alcohol. It may raise your chances of liver damage.

Do not receive a "live" vaccine, as it could lead to a serious infection. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, and varicella (chickenpox).

Do not drive or engage in hazardous activities until you know how RediTrex will affect you. Your reactions may be impaired.

Tell your doctor about all your other medicines, especially:

• an antibiotic or sulfa drug, folic acid, mercaptopurine, nitrous oxide, phenytoin, probenecid, dapsone, pyrimethamine;
• NSAIDs (nonsteroidal anti-inflammatory drugs)--aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others; or
• stomach acid reducers--esomeprazole, lansoprazole, omeprazole, pantoprazole, Nexium, Prilosec, Protonix, and others.

This list is not complete and many other drugs may affect RediTrex. This includes prescription and over-the-counter medicines, vitamins, and Herbal products. Not all possible drug interactions are listed here.