HYRIMOZ is a medicine called a Tumor Necrosis Factor (TNF)-blocker. HYRIMOZ is used:
- to reduce the signs and symptoms of:
- moderate to severe rheumatoid arthritis (RA) in adults. HYRIMOZ can be used alone, with methotrexate, or with certain other medicines.
- moderate to severe polyarticular juvenile idiopathic arthritis (JIA) in children 4 years and older. HYRIMOZ can be used alone, with methotrexate, or with certain other medicines.
- psoriatic arthritis (PsA) in adults. HYRIMOZ can be used alone or with certain other medicines.
- ankylosing spondylitis (AS) in adults.
- moderate to severe Crohn’s disease (CD) in adults when other treatments have not worked well enough.
- in adults, to help get moderate to severe ulcerative colitis (UC) under control (induce remission) and keep it under control (sustain remission) when certain other medicines have not worked well enough. It is not known if adalimumab products are effective in people who stopped responding to or could not tolerate TNF-blocker medicines.
- to treat moderate to severe chronic (lasting a long time) plaque psoriasis (Ps) in adults who have the condition in many areas of their body and who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light alone or with pills).
Side Effects Of Hyrimoz
HYRIMOZ can cause serious side effects, including:
Serious infections. Your doctor will examine you for TB and perform a test to see if you have TB. If your doctor feels that you are at risk for TB, you may be treated with medicine for TB before you begin treatment with Hyrimoz and during treatment with Hyrimoz. Even if your TB test is negative your doctor should carefully monitor you for TB infections while you are taking Hyrimoz. People who had a negative TB skin test before receiving adalimumab products have developed active TB. Tell your doctor if you have any of the following symptoms while taking or after taking Hyrimoz:
- cough that does not go away
- low grade fever
- weight loss
- loss of body fat and muscle
Cancer (Malignancy). Hyrimoz has an increased risk of developing certain cancers. Talk to your doctor to assess your risks.
Severe allergic reaction (Hypersensitivity). Tell your healthcare provider about any signs or symptoms of hypersensitivity, which include the following:
- Swelling of the face, eyes, lips, tongue, arms, or legs
- Difficulty breathing or swallowing
- Hepatitis B infection in people who carry the virus in their blood. If you are a carrier of the hepatitis B virus (a virus that affects the liver), the virus can become active while you are using Hyrimoz. Your doctor should do blood tests before you start treatment, while you are using Hyrimoz, and for several months after you stop treatment with Hyrimoz. Tell your doctor if you have any of the following symptoms of a possible hepatitis B infection:
- muscle aches
- feel very tired
- dark urine
- skin or eyes look yellow
- little or no appetite
- clay-colored bowel movement
- stomach discomfort
- skin rash
- Nervous system problems. Signs and symptoms of a nervous system problem include: numbness or tingling, problems with your vision, weakness in your arms or legs, and dizziness.
- Blood problems. Your body may not make enough of the blood cells that help fight infections or help to stop bleeding. Symptoms include a fever that does not go away, bruising or bleeding very easily, or looking very pale.
Heart Failure & When To Get Help” target=”_blank” rel=”noopener”>Heart Failure. Hyrimoz can lead to worsening of heart failure. Tell your healthcare provider right away if you have some or all of the following symptoms of worsening heart failure:
- Shortness of breath
- Extreme tiredness
- Abnormal heartbeats
- Immune reactions including a lupus-like syndrome. Symptoms include chest discomfort or pain that does not go away, shortness of breath, joint pain, or a rash on your cheeks or arms that gets worse in the sun. Symptoms may improve when you stop Hyrimoz.
- Liver Problems. Liver problems can happen in people who use TNF-blocker medicines. These problems can lead to liver failure and death. Call your doctor right away if you have any of these symptoms:
- feeling very tired
- poor appetite or vomiting
- skin or eyes look yellow
- pain on the right side of stomach (abdomen)
- Psoriasis. Some people using adalimumab products had new psoriasis or worsening of psoriasis they already had. Tell you doctor if you develop red scaly patches or raised bumps that are filled with pus. Your doctor may decide to stop your treatment with Hyrimoz.
Do not take Hyrimoz if you:
Are allergic to Hyrimoz or to any of its ingredients
Common side effects with HYRIMOZ include:
- injection site reactions: redness, rash, swelling, itching, or bruising. These symptoms usually will go away within a few days. Call your doctor right away if you have pain, redness, or swelling around the injection site that does not go away within a few days or gets worse.
- upper respiratory infections (including sinus infections)
These are not all the possible side effects of HYRIMOZ. Tell your doctor if you have any side effect that bothers you or that does not go away. Ask your doctor or pharmacist for more information.
Warnings & Precautions
HYRIMOZ may not be right for you. Before starting HYRIMOZ, tell your doctor about all of your health conditions, including if you:
- have an infection.
- have or have had cancer.
- have any numbness or tingling or have a disease that affects your nervous system such as multiple sclerosis or GuillainBarré syndrome.
- have or have had heart failure.
- have recently received or are scheduled to receive a vaccine. You may receive vaccines, except for live vaccines while using HYRIMOZ. Children should be brought up to date with all vaccines before starting HYRIMOZ.
- are allergic to rubber or latex. Tell your doctor if you have any allergies to rubber or latex.
- The following components contain dry natural rubber (a derivative of latex), which may cause allergic reactions in individuals sensitive to latex: the gray needle cap of the HYRIMOZ single-dose pre-filled syringe and the gray needle cover within the needle cap of the HYRIMOZ single-dose pre-filled Sensoready® Pen.
- are allergic to HYRIMOZ or to any of its ingredients
- are pregnant or plan to become pregnant. It is not known if HYRIMOZ will harm your unborn baby. HYRIMOZ should only be used during a pregnancy if needed.
- have a baby and you were using HYRIMOZ during your pregnancy. Tell your baby’s doctor before your baby receives any vaccines.
- are breastfeeding or plan to breastfeed. You and your doctor should decide if you will breastfeed or use HYRIMOZ. You should not do both.
- Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
- Especially tell your doctor if you use:
- ORENCIA® (abatacept), KINERET® (anakinra), REMICADE® (infliximab), ENBREL® (etanercept), CIMZIA® (certolizumab pegol), or SIMPONI® (golimumab), because you should not use HYRIMOZ while you are also using one of these medicines.
- RITUXAN® (rituximab). Your doctor may not want to give you HYRIMOZ if you have received RITUXAN® (rituximab) recently.
- IMURAN® (azathioprine) or PURINETHOL® (6–mercaptopurine, 6-MP).
Dosage Of Hyrimoz
HYRIMOZ is given by an injection under the skin. Your doctor will tell you how often to take an injection of HYRIMOZ. This is based on your condition to be treated. Do not inject HYRIMOZ more often than you were prescribed.
- See the Instructions for Use inside the carton for complete instructions for the right way to prepare and inject HYRIMOZ.
- Make sure you have been shown how to inject HYRIMOZ before you do it yourself. You can call your doctor or 1-800-525- 8747 if you have any questions about giving yourself an injection. Someone you know can also help you with your injection after they have been shown how to prepare and inject HYRIMOZ.
- Do not try to inject HYRIMOZ yourself until you have been shown the right way to give the injections. If your doctor decides that you or a caregiver may be able to give your injections of HYRIMOZ at home, you should receive training on the right way to prepare and inject HYRIMOZ.
- Do not miss any doses of HYRIMOZ unless your doctor says it is okay. If you forget to take HYRIMOZ, inject a dose as soon as you remember. Then, take your next dose at your regular scheduled time. This will put you back on schedule. In case you are not sure when to inject HYRIMOZ, call your doctor or pharmacist.
- If you take more HYRIMOZ than you were told to take, call your doctor.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use HYRIMOZ for a condition for which it was not prescribed. Do not give HYRIMOZ to other people, even if they have the same condition. It may harm them. This Medication Guide summarizes the most important information about HYRIMOZ. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about HYRIMOZ that is written for health professionals.
All information has been provided courtesy of MedLinePlus from the National Library of Medicine and from the FDA.