Hyrimoz

Hyrimoz is a prescription medication used to treat rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), Crohn’s disease (CD), ulcerative colitis (UC), and plaque psoriasis (Ps).

Hyrimoz belongs to a group of drugs called tumor necrosis factor (TNF) blockers. TNF is a protein that is overproduced in certain autoimmune conditions, causing inflammation and tissue destruction in joints, mucosa or skin. In some cases of autoimmune disease, the immune system damages the body’s own tissues. Hyrimoz targets and blocks the protein that contributes to disease symptoms.

Hyrimoz is available as a solution for injection under the skin in a pre-filled syringe or pen and is usually given every 2 weeks.

Common side effects of Hyrimoz include upper respiratory infection, headache, and rash.

Hyrimoz is a prescription medication 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).

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

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

Common side effects of Hyrimoz include the following:

• Upper respiratory infections (including sinus infections)
• 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.
• Headaches
• Rash

This is not a complete list of Hyrimoz side effects. Ask your doctor or pharmacist for more information.Tell your doctor if you have any side effects that bother you or that do 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:

• Methotrexate
• Biological products like anakinra (Kineret) and abatacept (Orencia)
• Live Vaccines like MMR, varicella, and zoster (Zostavax)
• Cytochrome P450 substrates like warfarin (Coumadin), cyclosporin (Sandimmune), theophylline (Uniphyl), and others

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

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

• 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:

  • Hives
  • Swelling of the face, eyes, lips, tongue, arms, or legs
  • Difficulty breathing or swallowing
  • Rash
• 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
  • vomiting
  • clay-colored bowel movement
  • fever
  • chills
  • 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. 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:

  • Cough
  • Shortness of breath
  • Extreme tiredness
  • Abnormal heartbeats
  • Swelling

• 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

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

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 Guillain- Barré 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. See the end of this Medication Guide for a list of ingredients in Hyrimoz.
• 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.

Tell your doctor if you 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. Talk to your doctor about your risks with using Hyrimoz.

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

Hyrimoz has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from Hyrimoz, 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. Talk to your doctor to assess the risks for your baby.

Take Hyrimoz exactly as prescribed.

• 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.

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

• your weight

Rheumatoid Arthritis:

The recommended dose of Hyrimoz (adalimumab-adaz) to manage and prevent progression of rheumatoid arthritis is 40 mg every other week.

Juvenile Idiopathic Arthritis:

The recommended dose of Hyrimoz (adalimumab-adaz) to manage signs and symptoms of moderate to severe active juvenile idiopathic arthritis in children 4 years of age and older with weight greater than or equal to 30 kg (66 lbs) is 40 mg every other week.

Psoriatic Arthritis:

The recommended dose of Hyrimoz (adalimumab-adaz) to manage and prevent progression of psoriatic arthritis is 40 mg every other week.

Ankylosing Spondylitis (arthritis of the spine and large joints):  

The recommended dose of Hyrimoz (adalimumab-adaz) to manage signs and symptoms of active ankylosing spondylitis is 40 mg every other week.

Adult Crohn’s Disease:

The recommended dose of Hyrimoz (adalimumab-adaz) to manage and prevent progression of moderate to severe adult Crohn’s disease is 160 mg initially on day 1, followed by 80 mg two weeks later (Day 15), and then 40 mg every other week start two week after last dose (Day 29).

Ulcerative Colitis:

The recommended dose of Hyrimoz (adalimumab-adaz) to manage and prevent progression of moderate to severe active ulcerative colitis is 160 mg initially on day 1, followed by 80 mg two weeks later (Day 15), and then 40 mg every other week start two week after last dose (Day 29).

Plaque Psoriasis:

The recommended dose of Hyrimoz (adalimumab-adaz) to treat moderate to severe chronic plaque psoriasis is 80 mg initially, followed by 40 mg every other week starting one week after initial dose.

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

• Store Hyrimoz in the refrigerator at 36°F to 46°F (2°C to 8°C). Do not Freeze.

• Hyrimoz, if needed, may be stored at room temperature for up to 14 days. Discard if not used in 14 days.

• Keep this and all medicines out of the reach of children.

Warning: Serious Infections and Malignancy

Serious Infections:

Patients treated with adalimumab products including Hyrimoz, are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.

Discontinue Hyrimoz if a patient develops a serious infection or sepsis.

Reported infections include:

• Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Test patients for latent TB before Hyrimoz use and during therapy. Initiate treatment for latent TB prior to Hyrimoz use.

• Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider empiric anti-fungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness.

• Bacterial, viral and other infections due to opportunistic pathogens, including Legionella and Listeria.

Carefully consider the risks and benefits of treatment with Hyrimoz prior to initiating therapy in patients with chronic or recurrent infection.

Monitor patients closely for the development of signs and symptoms of infection during and after treatment with Hyrimoz, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.

Malignancy:  

Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF-blockers including adalimumab products. Post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF-blockers including adalimumab products. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF-blocker cases have occurred in patients with Crohn's disease or ulcerative colitis and the majority were in adolescent and young adult males. Almost all these patients had received treatment with azathioprine or 6-mercaptopurine (6–MP) concomitantly with a TNF-blocker at or prior to diagnosis. It is uncertain whether the occurrence of HSTCL is related to use of a TNF-blocker or a TNF-blocker in combination with these other immunosuppressants.