Rasuvo

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

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

Common side effects of Rasuvo include nausea, mouth sores and diarrhea.

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

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

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

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

Common side effects of Rasuvo include the following:

• nausea
• fatigue
• indigestion
• mouth sores
• stuffy or runny nose
• sore throat
• dizziness
• drowsiness
• blurred vision
• diarrhea
• vomiting
• headache
• decrease in blood counts
• burning skin lesions
• sensitivity to light
• skin rash
• itching
• hair loss
• stomach pain

This is not a complete list of Rasuvo 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:

• Azathioprine
• Sulfasalazine
• Theophylline
• Folic acid
• Mercaptopurine
• Phenylbutazone
• Phenytoin
• Hydroxychloroquine
• Nonsteroidal anti-inflammatory drugs (NSAIDs). If you are unsure if you are taking any of these medications, 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.
• Oral Antibiotics. 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.
• Retinoid medications. 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.

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

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

• Fertility problems. Rasuvo, may affect your ability to have a baby. Males may have a decreased sperm count, and females may have changes to their menstrual cycle. This can happen while taking Rasuvo and for a short period of time after you stop. 
• Certain cancers. Rasuvo may lead to Non-Hodgkin's lymphoma and other tumors. Consult with your physician about your risk for developing lymphoma or other tumors during your treatment with Rasuvo. Your doctor may tell you to stop taking Rasuvo if this happens.
• Tissue and bone problems. Taking methotrexate 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.
• Organ system toxicity. Rasuvo 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 physician will monitor you for development of toxicity during the course of your therapy with Rasuvo. It is important to promptly inform your physician of any new side effects that develop during treatment. Your doctor will do blood tests and other types of tests before you take and while you are taking Rasuvo to check for signs and symptoms of organ toxicity. Call your doctor right away if you have any of the following symptoms of organ toxicity:
  • vomiting
  • diarrhea
  • mouth sores
  • confusion
  • neck stiffness
  • paralysis
  • problems with coordination
  • temporary blindness
  • severe skin rash
  • trouble breathing
• Harm to unborn baby. Women who are pregnant are at increased risk for death of the baby and birth defects. Women who are pregnant or who plan to become pregnant must not take Rasuvo. A pregnancy test should be performed before starting Rasuvo. Contraception should be used by both females and males while taking Rasuvo. Pregnancy should be avoided if either partner is receiving Rasuvo:
  • for a minimum of 3 months after treatment with Rasuvo for males.
  • during and for at least 1 menstrual cycle after treatment with Rasuvo for females.

Rasuvo can also cause dizziness and drowsiness. Do not drive or operate heavy machinery until you know how Rasuvo affects you.

Do not drink alcohol while taking Rasuvo. Drinking alcohol can increase your chances of getting serious side effects

Certain vaccinations should be avoided while taking Rasuvo. Talk to your doctor before you or members of your household receive any vaccines.

Do not take Rasuvo if you:

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

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 Rasuvo, there are no specific foods that you must exclude from your diet when receiving this medication.

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

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

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.

Rasuvo falls into category X. It has been shown that women taking Rasuvo 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.

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

Take Rasuvo exactly as prescribed.

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

• Rasuvo should be injected under the skin of the abdomen or thigh.
• Do not inject Rasuvo within 2 inches of the belly button (navel)
• Use a different site each time you inject. This may help to decrease any reactions at the injection site.
• Do not inject Rasuvo in the arms or any other areas of the body.
• Do not inject Rasuvo in areas where the skin is tender, bruised, red, scaly, hard, or has scars or stretch marks.

Do not take Rasuvo every day. Taking Rasuvo every day may cause death from toxicity.

Check Rasuvo before you inject it. Rasuvo should be yellow to brown in color and should not have any lumps or particles in it.

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

You may be shown how to use Rasuvo 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.

For additional information on proper administration of Rasuvo, you may refer to the following section.

Preparing to Use Rasuvo

1. Wash your hands well with soap and warm water
2. Select a clean, well-lit, flat work surface, such as a table
3. Place the Rasuvo carton containing the auto-injector on your flat work surface. Be sure that the dose, either 7.5, 10, 12.5, 15, 17.5, 20, 22.5, 25, 27.5 or 30 mg, stated on the carton is the same as the dose prescribed by your doctor
4. Check the expiration date on the label. Do not use if expired
5. Remove one Rasuvo auto-injector from the packaging. If the Rasuvo appears to be damaged do not use it. Use another Rasuvo. In addition to Rasuvo, you will need the following items: one alcohol swab and one cotton ball or gauze and small adhesive bandage strip, if desired
6. Look at the transparent control zone. The prefilled syringe is visible within the transparent control zone. Examine the contents of the syringe carefully. If the syringe is cracked or broken, do not use it. Use another auto-injector. The liquid should be clear and yellow to brown in color and should not have any lumps or particles in it. Do not use Rasuvo if the liquid is cloudy, discolored or contains particles. You may see an air bubble. This is normal. If you are not able to see or to check the Rasuvo auto-injector correctly prior to injection, ask a caretaker for assistance. Do not remove the yellow cap from the auto-injector until you are ready to use Rasuvo

Choosing an Injection Site

1. Wipe the area with an alcohol swab
2. Allow the skin to dry and do not touch this area again before giving Rasuvo. Do not fan or blow on the clean area. 
3. Rasuvo should be injected into the stomach (abdomen) or the upper thigh.
4. Use a different site each time you inject. This may help to decrease any reactions at the injection site

Giving your Injection

1. Hold the Rasuvo auto-injector with one hand in the handling area
2. Use your other hand to pull the yellow cap straight off. Do not twist the cap. If you are unable to remove the cap, ask a caretaker for assistance. You may notice 1 or 2 drops of medicine. This is normal.
3. Do not touch the needle end with your hands or fingers. This could inject the medicine into your hand. To avoid any injury, never insert your fingers in the opening of the protect tube covering the needle. Do not replace the cap after it has been removed. After the cap is removed Rasuvo must be used without delay or disposed of safely. Do not press the yellow injection button until you are ready to inject Rasuvo.
4. Pinch a pad of skin surrounding the cleaned injection site with your thumb and forefinger of your free hand by gently squeezing. Patients with rheumatoid arthritis who are unable to pinch the skin can inject directly into the thigh without pinching if needed.
5. Hold the skin pinched until Rasuvo is removed from the skin after the injection.
6. Position the uncapped transparent end of the Rasuvo auto-injector perpendicular (at a 90 degree angle) to the skin.
7. Without pressing the button, push Rasuvo firmly onto your skin until you feel the stop point in order to unlock the yellow injection button. If you are unable to push Rasuvo to the stop-point, ask a caretaker for assistance.
8. While still holding Rasuvo firmly against the skin, press the yellow injection button with your thumb. You will hear a click which indicates the start of the injection.
9. Hold Rasuvo against the skin until all of the medicine is injected. This can take up to 5 seconds (slowly count 1, 2, 3, 4, 5). To avoid an incomplete injection, do not remove the Rasuvo from the skin before the end of the injection.
10. Look at the transparent control zone while you are injecting to make sure that the entire dose is injected. When the movement stops, the injection is completed. If you have problems with your hearing, slowly count to 5 seconds from the moment you have pressed the button. It is not necessary to keep the button of the Rasuvo pressed down with your thumb after the injection has begun.
11. After completing the injection, remove Rasuvo from the injection site by pulling straight up (perpendicular to the skin). The protective needle shield automatically moves into place and locks over the needle.
12. Put a small adhesive bandage strip over the injection site, if desired.

Checking the Transparent Control Zone

1. Check visually to make sure that there is no liquid left in the syringe inside the transparent control zone. If there is liquid left, not all of the medicine has been injected correctly. Consult your doctor or health care professional immediately. Do not use another Rasuvo, unless advised by your doctor.

Disposal of Rasuvo

• Each Rasuvo can be used only 1 time
• Do not throw away in the household trash. Put used Rasuvo in an FDA-cleared sharps disposal container right away after use.
• If you do not have an 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 Rasuvo that is out of date or no longer needed

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 Rasuvo 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 Rasuvo 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.

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

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

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

• Rasuvo 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), Rasuvo 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 Rasuvo 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.
• Rasuvo has been reported to cause fetal death and/or congenital anomalies. Therefore, Rasuvo 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. Rasuvo is contraindicated in pregnant women.
• Rasuvo 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 Rasuvo administration.
• Unexpectedly severe (sometimes fatal) bone marrow suppression, aplastic anemia, and gastrointestinal toxicity have been reported with concomitant administration of Rasuvo (usually in high dosage) along with some nonsteroidal anti-inflammatory drugs (NSAIDs).
• Rasuvo 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.
• Rasuvo-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.
• Malignant lymphomas, which may regress following withdrawal of Rasuvo, may occur in patients receiving low-dose Rasuvo and, thus, may not require cytotoxic treatment. Discontinue Rasuvo first and, if the lymphoma does not regress, appropriate treatment should be instituted.
• Like other cytotoxic drugs, Rasuvo 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 Rasuvo. Recovery has been reported with discontinuation of therapy.
• Potentially fatal opportunistic infections, especially Pneumocystis jiroveci pneumonia, may occur with Rasuvo therapy.
• Rasuvo given concomitantly with radiotherapy may increase the risk of soft tissue necrosis and osteonecrosis.