What is Otrexup?

Use only for severe rheumatoid arthritis and psoriasis unresponsive to other therapies. Monitor for bone marrow, liver, lung, skin, and kidney toxicities. Death, fetal death and/or congenital anomalies, and severe sometimes fatal lung disease, tumor lysis syndrome, skin reactions, and Pneumocystis jiroveci pneumonia have been reported. Use not recommended in women of childbearing potential and is contraindicated in pregnant women. Unexpectedly severe (sometimes fatal) bone marrow suppression, aplastic anemia, and gastrointestinal toxicity have been reported with concomitant administration of methotrexate (usually in high dosage) along with some NSAIDs. Hepatotoxicity, fibrosis, and cirrhosis may occur with prolonged use. Diarrhea and ulcerative stomatitis require therapy interruption. Methotrexate elimination is reduced in patients with impaired renal function, ascites, or pleural effusions; dose reduction is required and discontinuation may be necessary with these conditions. Increased risk of soft tissue necrosis and osteonecrosis with concomitant radiotherapy. Malignant lymphoma may occur .

Only use for life-threatening neoplastic disease or severe rheumatoid arthritis and psoriasis unresponsive to other therapies. Death, fetal death and/or congenital anomalies, lung disease, tumor lysis syndrome, fatal skin reactions, and Pneumocystis carinii pneumonia have been reported. Monitor for bone marrow, liver, lung, and kidney toxicities. Unexpectedly severe (sometimes fatal) bone marrow suppression, aplastic anemia, and gastrointestinal toxicity have been reported with concomitant administration of methotrexate (usually in high dosage) along with some nonsteroidal anti-inflammatory drugs (NSAIDs). Hepatotoxicity, fibrosis, and cirrhosis occur with prolonged use. Diarrhea and ulcerative stomatitis require interruption of therapy. Methotrexate elimination is reduced in patients with impaired renal function, ascites, or pleural effusions. Increased risk of soft tissue necrosis and osteonecrosis with concomitant radiotherapy. Malignant lymphoma may occur. Use extreme caution with high-dose regimen for osteosarcoma. Do not use formulations/diluents with preservatives for intrathecal or high-dose therapy .

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 is also used to treat adults with severe rheumatoid arthritis and children with polyarticular juvenile idiopathic arthritis who had other treatments that did not work well. It is also used to control symptoms of severe psoriasis in adults who have not been helped by other treatments.

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.

A nurse or other trained health professional will give you this medicine in a hospital or cancer treatment center. This medicine is given as a shot under your skin, into a muscle, into a vein, or into your spine (back or neck).

If you are using the Otrexup™ or Rasuvo™ 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.

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 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 or juvenile arthritis:
    • Adults—At first, 7.5 milligrams (mg) once per week. Your doctor may adjust your dose as needed.
    • Children—Dose is based on body size and must be determined by your doctor. The starting dose is 10 milligrams (mg) per square meter (m(2)) of body size once per week. Your doctor may adjust your dose as needed.

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.

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.

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:

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 geriatric-specific problems that would limit the usefulness of methotrexate injection in the elderly. However, elderly patients are more likely to have liver or kidney problems, which may require caution and an adjustment in the dose in patients receiving methotrexate injection.

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.

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

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aceclofenac
• Acemetacin
• Adenovirus Vaccine
• Amoxicillin
• Amtolmetin Guacil
• Asparaginase
• Aspirin
• Bacillus of Calmette and Guerin Vaccine, Live
• Beet Root
• Bentiromide
• Bromfenac
• Bufexamac
• Capecitabine
• Celecoxib
• Chloral Hydrate
• Cholera Vaccine, Live
• Choline Salicylate
• Clonixin
• Dantrolene
• Dasabuvir
• Dexibuprofen
• Dexketoprofen
• Dexlansoprazole
• Diclofenac
• Dicloxacillin
• Diflunisal
• Dipyrone
• Doxifluridine
• Doxycycline
• Droxicam
• Esomeprazole
• Etodolac
• Etofenamate
• Felbinac
• Fenbufen
• Fenoprofen
• Fepradinol
• Feprazone
• Floctafenine
• Floxacillin
• Flufenamic Acid
• Fluorouracil
• Flurbiprofen
• Foscarnet
• Fosphenytoin
• Hydrochlorothiazide
• Ibuprofen
• Ibuprofen Lysine
• Indomethacin
• Influenza Virus Vaccine, Live
• Ketoprofen
• Ketorolac
• Leflunomide
• Levetiracetam
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Mezlocillin
• Morniflumate
• Nabumetone
• Naproxen
• Nepafenac
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Nitrous Oxide
• Omeprazole
• Oxaprozin
• Oxyphenbutazone
• Pantoprazole
• Parecoxib
• Penicillin G
• Penicillin V
• Phenylbutazone
• Phenytoin
• Piketoprofen
• Piperacillin
• Piroxicam
• Pirprofen
• Poliovirus Vaccine, Live
• Pristinamycin
• Probenecid
• Proglumetacin
• Propionic Acid
• Propyphenazone
• Proquazone
• Pyrimethamine
• Rabeprazole
• Salicylic Acid
• Salsalate
• Simeprevir
• Smallpox Vaccine
• Sodium Salicylate
• Sulfamethizole
• Sulfamethoxazole
• Sulfapyridine
• Sulfisoxazole
• Sulindac
• Tamoxifen
• Tegafur
• Tenoxicam
• Teriflunomide
• Tiaprofenic Acid
• Ticarcillin
• Tolfenamic Acid
• Tolmetin
• Tolvaptan
• Triamterene
• Trimethoprim
• Typhoid Vaccine
• Valdecoxib
• Warfarin
• Yellow Fever Vaccine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amiodarone
• Cyclosporine
• Eltrombopag
• Etoricoxib
• Mercaptopurine
• Procarbazine
• Rofecoxib
• Theophylline

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. 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 is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Cola

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol abuse, or history of or
• Anemia or
• Leukopenia (low white blood cells) or
• Liver disease, severe or
• Thrombocytopenia (low platelet blood level) or
• Weak immune system—Should not be used in patients with these conditions.

• Ascites (extra fluid in the stomach area) or
• Kidney disease or
• Pleural effusion (extra fluid in the lung)—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Diabetes or
• Liver disease or
• Obesity or
• Peptic ulcers or
• Ulcerative colitis (inflammation of the colon)—Use with caution. May cause side effects to become worse.

• Infection (bacteria, fungus, virus)—Use with caution. May decrease your ability to fight an infection.

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects. Blood tests and chest x-rays may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. The medicine may also cause birth defects if it is used by the father when his sexual partner becomes pregnant. Men should use birth control during and for at least 3 months after the last dose. Women should use birth control during and for at least one menstrual cycle after the last dose. Tell your doctor right away if pregnancy occurs while you are using this medicine.

Talk with your doctor before using this medicine if you plan to have children. Some men and women who use this medicine have become infertile (unable to have children).

Limit alcohol use with this medicine. Alcohol may increase the risk for liver problems.

This medicine may cause organ system toxicity. Call your doctor right away if you have the following symptoms: a fever, confusion, diarrhea, dry cough, irritability, neck stiffness, seizures, severe skin rash, sleepiness, trouble breathing, weakness, vomiting, or problems with coordination.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Methotrexate can lower the number of white blood cells in your blood, which increases the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately 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 difficult urination.
• Check with your doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could occur.

While you are being treated with methotrexate, and after you stop treatment with it, do not have any immunizations (vaccines) without your doctor's approval. Methotrexate may lower your body's resistance and the vaccine may not work as well or you might get the infection the vaccine is meant to prevent. In addition, you should not be around other persons living in your household who receive live virus vaccines because there is a chance they could pass the virus on to you. Some examples of live vaccines include measles, mumps, influenza (nasal flu vaccine), poliovirus (oral form), rotavirus, and rubella. Do not get close to them and do not stay in the same room with them for very long. If you have questions about this, talk to your doctor.

Serious skin reactions can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, red skin lesions, severe acne or a skin rash, sores or ulcers on the skin, or fever or chills while you are using this medicine.

This medicine may make your skin more sensitive to sunlight. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds.

This medicine may make you dizzy or tired. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

This medicine may increase your risk of having a lymphoma (cancer of the lymph system). Discuss these possible effects with your doctor.

This medicine may cause a serious reaction called tumor lysis syndrome. Tell your doctor right away if you have a change in urine amount, joint pain, stiffness, or swelling, lower back, side, or stomach pain, rapid weight gain, swelling of the feet or lower legs, or unusual tiredness or weakness.

Using this medicine with radiation therapy may increase risk of tissue or bone problems, such as tissue or bone not receiving enough blood. Tell your doctor if you are receiving other treatments, such as radiation therapy, while using this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.