Otrexup

Otrexup is a prescription medication used to treat psoriasis, rheumatoid arthritis, and polyarticular juvenile idiopathic arthritis. Otrexup belongs to a group of drugs called dihydrofolic acid reductase inhibitors. These work to treat psoriasis, rheumatoid arthritis, and polyarticular juvenile idiopathic arthritis through a mechanism that is currently not yet fully understood, but is believed to affect immune function.

This medication is available in an injectable form to be given directly under the skin, typically once per week.

Common side effects of Otrexup include nausea, stomach upset, and diarrhea.

Otrexup can also cause dizziness, drowsiness, and/or blurred vision. Do not drive or operate heavy machinery until you know how Otrexup affects you.

Otrexup is a prescription medication used to treat severe disabling psoriasis in adults, severe active rheumatoid arthritis in adults, and polyarticular juvenile idiopathic arthritis in children.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Antares Pharma Inc.

Serious side effects have been reported with Otrexup. See the “Otrexup Precautions” section.

Common side effects of Otrexup include the following:

• itching

This is not a complete list of Otrexup side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• Theophylline
• Azathioprine
• Phenylbutazone
• Phenytoin
• Hydroxychloroquine
• Folic acid
• Mercaptopurine
• Sulfasalazine
• Retinoid medications. If you are unsure if you are taking any of these medications, consult with your pharmacist.
• Oral Antibiotics. If you are unsure if you are taking any of these medications, consult with your pharmacist.
• Antifolate medications. If you are unsure if you are taking any of these medications, consult with your pharmacist.
• Nonsteroidal anti-inflammatory drugs (NSAIDs). If you are unsure if you are taking any of these medications, consult with your pharmacist.
• Live vaccines. If you are unsure if you have received any live vaccines, consult with your pharmacist.
• Proton Pump Inhibitors (PPIs) and H2 Blockers. If you are unsure if you are taking any of these medications, consult with your pharmacist.

This is not a complete list of Otrexup drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Otrexup including the following:

• Toxic effects on multiple organ systems. Otrexup has been reported to have toxic effects on the gastrointestinal and immune systems in addition to the blood, blood-forming organs, liver, lungs, kidneys, and skin. Your doctor will order blood tests and other types of tests before you take and while you are using  Otrexup. Call your doctor immediately if you experience any of the following symptoms:
  • vomiting/diarrhea
  • mouth sores
  • fever
  • confusion
  • weakness
  • temporary blindness
  • seizures
  • headache
  • back pain/ neck stiffness
  • paralysis
  • problems with coordination
  • severe skin reaction
  • infection
• Risk of toxicity due to improper dosing. It is very important that you only administer Otrexup once per week. If Otrexup is used more often than once per week, potentially fatal toxicity can develop.
• Harm to your unborn baby. Women who are pregnant are at an increased risk for death of the baby and birth defects. Women who are pregnant or who plan to become pregnant should not take Otrexup. Your doctor will perform a pregnancy test before initiating Otrexup. Women and Men who are of reproductive age should use effective contraception while taking Otrexup. Avoid pregnancy:
  • for a minimum of 3 months after Otrexup treatment for males
  • during and for at least 1 menstrual cycle after treatment with Otrexup for females
• Fertility problems. Otrexup can affect your ability to have a baby. Males may have a decreased sperm count, and females may have changes in their menstrual cycle. This can even occur for a short period after you stop taking Otrexup. 
• Certain cancers. Some people who have taken Otrexup have had a certain type of cancer called Non-Hodgkin's lymphoma and other tumors. If this occurs, you doctor may tell you to stop taking Otrexup. 
• Tissue and bone problems. Taking Otrexup while having radiation therapy may increase the risk of your tissue or bone not receiving enough blood. This may lead to death of the tissue or bone. 

Otrexup can also cause dizziness, drowsiness, and/or blurred vision. Do not drive or operate heavy machinery until you know how Otrexup affects you.

Do not take Otrexup if you:

• are allergic to Otrexup or to any of its ingredients 
• have bone marrow hypoplasia, leukopenia, thrombocytopenia, or anemia
• have any immunodeficiency syndromes
• have liver disease
• are pregnant, plan to become pregnant, or suspect you might be pregnant
• are breastfeeding or plan to breastfeed

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Otrexup, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Otrexup, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Otrexup or to any of its ingredients
• have liver disease
• have kidney disease
• have ascites
• have lung problems
• have problems fighting infection (immunodeficiency syndromes)
• have received any vaccines
• have a blood disorder such as low white blood cells, red blood cells, or platelets
• have any active cancers
• drink alcohol or have alcohol problems (alcoholism)
• are pregnant, plan to become pregnant, or suspect you might be pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Otrexup falls into category X. It has been shown that women taking Otrexup during pregnancy may have babies born with problems. There are no situations where the benefits of the medication for the mother outweigh the risks of harm to the baby. These medicines should never be used by pregnant women.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Otrexup has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from Otrexup, a choice should be made whether to stop nursing or to stop use of this medication. The importance of the drug to the mother should be considered. Nursing mothers should not breastfeed if using Otrexup. 

Take Otrexup exactly as prescribed.

Otrexup comes in an injectable form to be given directly under the skin, typically once per week.

• Otrexup is to be injected in the stomach or thigh.
• Do not inject Otrexup within 2 inches of the belly button.
• Do not inject  Otrexup in the arms or any other areas of the body
• Do not inject Otrexup in areas where the skin is tender, bruised, red, hard, has scars, or has stretch marks. 

You may be shown how to use Otrexup injections at home. Do not self-inject this medicine if you do not understand how to give the injection and properly dispose items used to inject the medicine.

Always follow your physician's instructions on use exactly. For additional information on proper administration of Otrexup, you may refer to the following section.

Preparing to Use Otrexup

1. Wash your hands well with soap and warm water; do not remove cap or safety clip until you are ready to inject Otrexup
2. Check the expiration date on the label; do not use if expired
3. Check the seal; do not use Otrexup if the seal is broken; in addition to Otrexup, you will need the following items: 1 alcohol swab and 1 cotton ball or gauze
4. Look at the viewing window; the liquid should be yellow in color and should not have any lumps or particles in it; you may see an air bubble; this is normal
5. Choose an Injection site; Otrexup should be injected into the stomach (abdomen) or thigh
6. Wipe the area with an alcohol swab
7. Allow the skin to dry and do not touch this area again before giving Otrexup; do not fan or blow on the clean area

1. Remove cap; twist cap to remove, this will break the seal; you may notice 1 or 2 drops of medicine, this is normal; do not touch the needle end with your hands or fingers, this could inject the medicine into your hand; do not replace the cap after it has been removed, after the cap is removed Otrexup must be used or disposed of safely
2. Remove the Safety clip
3. Place the needle end of Otrexup flat against thigh or stomach (abdomen) at a 90° and firmly push device against the injection site until fully depressed; you will hear a click, hold for 3 seconds
4. After counting to 3, remove Otrexup from the injection site; you may notice a small amount of blood or liquid at the administration site, which is normal
5. Press a cotton ball or gauze on the area for 10 seconds; do not rub the area
6. Check the viewing window; the viewing window will be half blocked with a red flag to show that the full dose was delivered; if the viewing window is not half blocked with a red flag, call your doctor or pharmacist for help
7. Do not use another Otrexup without talking to your doctor

Disposal of Otrexup

• Do not throw away in the household trash, put used Otrexup in a FDA-cleared sharps disposal container right away after use
• If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:
  • made of a heavy-duty plastic
  • can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out
  • upright and stable during use
  • leak-resistant
  • properly labeled to warn of hazardous waste inside the container
• When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container; there may be state or local laws about how you should throw away used needles and syringes
• For more information about the safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA’s website at: http://www.fda.gov/safesharpsdisposal
• Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this
• Do not recycle your used sharps disposal container
• Safely dispose of Otrexup that is out of date or no longer needed

If you are not sure if Otrexup was injected or if you have a hard time giving the injection, do not inject another dose. Call your doctor or pharmacist immediately. 

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your age
• your height

The recommended dose range of Otrexup for the treatment of psoriasis is 10 mg - 25 mg injected under the skin (subcutaneously), typically once per week.

The recommended dose range of Otrexup for the treatment of rheumatoid arthritis is 7.5 mg - 20 mg injected under the skin (subcutaneously), typically once per week.

The recommended dose range of Otrexup for the treatment of polyarticular juvenile idiopathic arthritis is 10 mg - 20 mg per square meter of body surface area injected under the skin (subcutaneously), typically once per week.

If you take too much Otrexup, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store Otrexup at room temperature between 68°F to 77°F (20°C to 25°C)
• Keep Otrexup out of the light
• Do not freeze
• Always keep your Otrexup out of the reach of children

• Otrexup should be used only by physicians whose knowledge and experience include the use of antimetabolite therapy. Because of the possibility of serious toxic reactions (which can be fatal), Otrexup should be used only in patients with psoriasis or rheumatoid arthritis with severe, recalcitrant, disabling disease which is not adequately responsive to other forms of therapy. Deaths have been reported with the use of Otrexup in the treatment of malignancy, psoriasis, and rheumatoid arthritis. Patients should be closely monitored for bone marrow, liver, lung, skin, and kidney toxicities. Patients should be informed by their physician of the risks involved and be under a physician's care throughout therapy.
• Potentially fatal opportunistic infections, especially Pneumocystis jiroveci pneumonia, may occur with Otrexup therapy.
• Otrexup given concomitantly with radiotherapy may increase the risk of soft tissue necrosis and osteonecrosis.
• Otrexup causes hepatotoxicity, fibrosis and cirrhosis, but generally only after prolonged use. Acutely, liver enzyme elevations are frequently seen. These are usually transient and asymptomatic, and also do not appear predictive of subsequent hepatic disease. Liver biopsy after sustained use often shows histologic changes, and fibrosis and cirrhosis have been reported; these latter lesions may not be preceded by symptoms or abnormal liver function tests in the psoriasis population. For this reason, periodic liver biopsies are usually recommended for psoriatic patients who are under long-term treatment. Persistent abnormalities in liver function tests may precede appearance of fibrosis or cirrhosis in the rheumatoid arthritis population.
• Otrexup has been reported to cause fetal death and/or congenital anomalies. Therefore, Otrexup is not recommended for females of childbearing potential unless there is clear medical evidence that the benefits can be expected to outweigh the considered risks. Otrexup is contraindicated in pregnant women.
• Otrexup-induced lung disease, including acute or chronic interstitial pneumonitis, is a potentially dangerous lesion, which may occur acutely at any time during therapy and has been reported at low doses. It is not always fully reversible and fatalities have been reported. Pulmonary symptoms (especially a dry, nonproductive cough) may require interruption of treatment and careful investigation.
• Diarrhea and ulcerative stomatitis require interruption of therapy: otherwise, hemorrhagic enteritis and death from intestinal perforation may occur.
• Otrexup elimination is reduced in patients with impaired renal functions, ascites, or pleural effusions. Such patients require especially careful monitoring for toxicity, and require dose reduction or, in some cases, discontinuation of Otrexup administration.
• Unexpectedly severe (sometimes fatal) bone marrow suppression, aplastic anemia, and gastrointestinal toxicity have been reported with concomitant administration of Otrexup (usually in high dosage) along with some nonsteroidal anti-inflammatory drugs (NSAIDs).
• Malignant lymphomas, which may regress following withdrawal of Otrexup, may occur in patients receiving low-dose Otrexup and, thus, may not require cytotoxic treatment. Discontinue Otrexup first and, if the lymphoma does not regress, appropriate treatment should be instituted.
• Like other cytotoxic drugs, Otrexup may induce "tumor lysis syndrome" in patients with rapidly growing tumors.
• Severe, occasionally fatal, skin reactions have been reported following single or multiple doses of Otrexup. Recovery has been reported with discontinuation of therapy.