Hyrimoz Prefilled Pen

Hyrimoz Prefilled Pen is used on its own or together with certain other medicines.

Hyrimoz Prefilled Pen is used to treat juvenile idiopathic arthritis in adults and children who are at least 2 years old.

Hyrimoz Prefilled Pen is also used for treating Crohn's disease in adults and children who are at least 6 years old.

Hyrimoz Prefilled Pen may also be used in adults to treat other conditions such as uveitis, ulcerative colitis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis, and hidradenitis suppurativa.

Hyrimoz Prefilled Pen may also be used for purposes that are not listed in this medication guide.

You may get infections more easily, including serious or fatal infections. Call your doctor if you have flu symptoms, a cough, night sweats, neck stiffness, confusion, or vision problems. Before using Hyrimoz Prefilled Pen, your doctor should test you for tuberculosis or other infections.

If you've had hepatitis B, it may return or worsen after you stop using Hyrimoz Prefilled Pen. Inform your doctor if you feel unwell and have pain in the upper right side of your stomach, vomiting, loss of appetite, or yellowing of your skin or eyes. You may need liver function tests for several months.

Before you start using Hyrimoz Prefilled Pen, tell your doctor if you have any signs of infection such as fever, chills, cough, body aches, tiredness, open sores or skin wounds, diarrhea, stomach pain, weight loss, painful urination, or coughing up blood.

Tell your doctor if you've had or been exposed to tuberculosis or a fungal infection, or if you recently traveled or plan to travel. Some infections are more common in certain parts of the world, and you may be exposed during travel.

Tell your doctor if you have or have ever had:

• tuberculosis (or if anyone in your household has tuberculosis);
• an active or chronic infection;
• cancer;
• hepatitis B (Hyrimoz Prefilled Pen can cause hepatitis B to come back or get worse);
• diabetes;
• congestive heart failure;
• any numbness or tingling, or a nerve-muscle disorder such as multiple sclerosis or Guillain-Barre syndrome;
• an allergy to latex or rubber;
• scheduled to have major surgery; or
• recently received or are scheduled to receive any vaccine.

Make sure you are current on all vaccines before you start using Hyrimoz Prefilled Pen.

Using Hyrimoz Prefilled Pen may increase your risk of developing other cancers. Ask your doctor about this risk.

It is not known if Hyrimoz Prefilled Pen will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Tell your baby's doctor if you used Hyrimoz Prefilled Pen during pregnancy. It could affect your baby's vaccination schedule.

Ask a doctor if it is safe to breastfeed while using Hyrimoz Prefilled Pen.

Get emergency medical help if you have signs of an allergic reaction: hives, trouble breathing, swelling of your face, lips, tongue, or throat.

Call your doctor immediately if you have any symptoms of lymphoma:

• fever, swollen glands, body aches, night sweats, feeling unwell;
• pale skin, rash, easy bruising or bleeding;
• cold hands and feet, feeling light-headed or short of breath;
• pain in your upper stomach that may spread to your shoulder; or
• feeling full after eating only a small amount, weight loss.

Also call your doctor right away if you have:

• skin changes such as red scaly patches or pus-filled bumps;
• new or worsening heart problems—swelling, rapid weight gain, feeling short of breath;
• easy bruising or bleeding, unusual weakness;
• liver problems—loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• lupus-like symptoms—muscle or joint pain, flu symptoms, chest pain, and a rash or patchy skin color that worsens in sunlight;
• nervous system problems—numbness, pain, tingling, weakness, burning or prickly feeling, vision or hearing problems, trouble breathing; or
• signs of tuberculosis—fever, cough, night sweats, loss of appetite, weight loss, and feeling very tired.

Your treatments may be delayed or stopped permanently if you have certain side effects.

Common side effects of Hyrimoz Prefilled Pen may include:

• headache, skin rash;
• cold symptoms such as stuffy nose, sinus pain, sneezing, sore throat; or
• bruising, swelling, warmth, redness, oozing, or bleeding where the injection was given.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Hyrimoz Prefilled Pen is injected under the skin. A healthcare provider will teach you how to properly use this medicine by yourself. Do not inject into the same place two times in a row.

Prepare an injection only when you are ready to give it. Call your pharmacist if the medicine looks cloudy, has changed colors or has particles in it. Ask your doctor or pharmacist if you don't understand how to use an injection.

Doses are based on weight in children and teenagers. Your child's dose may change if the child gains or loses weight.

You may get infections more easily, even serious or fatal infections. You will need frequent medical tests.

Before you use Hyrimoz Prefilled Pen, your doctor will test you for tuberculosis or other infections. Your blood will be tested before and during treatment with this medicine.

If you've had hepatitis B, it may come back or get worse during the treatment or after you stop using Hyrimoz Prefilled Pen. You may need liver function tests while using this medicine and for several months after you stop.

Store this medicine in its original container in the refrigerator, do not freeze. Protect from light. Carefully follow all instructions for storing your medicine during travel. Avoid extreme heat or cold.

Take the medicine out of the refrigerator and let it reach room temperature for 30 minutes before using. Do not warm the medicine with hot water, sunlight, or a microwave.

Throw away a prefilled syringe or auto-injector after one use, even if there is still medicine left inside.

Do not reuse a needle or syringe. Place them in a puncture-proof "sharps" container and dispose of it following state or local laws. Keep out of the reach of children and pets.

Use the medicine as soon as you remember, and then return to your regular schedule. Do not use two doses at once.

Seek emergency medical help or call the Poison Help line at 1-800-222-1222.

Do not inject into skin that is hard, red, bruised, swollen, or tender.

Avoid being around people who are sick or have infections. Tell your doctor immediately if you notice signs of infection.

Do not receive a "live" vaccine, or you could develop a serious infection. Live vaccines may include measles, mumps, rubella (MMR), varicella (chickenpox), nasal flu vaccine, and others.

Sometimes it is not safe to use certain medicines at the same time. Some drugs can change the levels of other drugs in your blood, which may increase side effects or make the medicines less effective.

Tell your doctor about all your other medicines, especially:

• abatacept, etanercept;
• anakinra;
• azathioprine, 6-mercaptopurine; or
• certolizumab, golimumab, infliximab, rituximab.

This list is not complete. Other drugs may affect Hyrimoz Prefilled Pen, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Find detailed information on biosimilars for this medication.