Yusimry

Yusimry (adalimumab-aqvh) is an interchangeable biosimilar to Humira. It is a TNF alfa inhibitor used to reduce pain, inflammation, and skin symptoms in chronic autoimmune conditions. Yusimry is used to treat rheumatoid arthritis (RA), juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, and uveitis.

Biosimilars are biologic medicines that are highly similar to an FDA-approved reference product, with no clinically meaningful differences in safety or effectiveness. Yusimry is also interchangeable with Humira, which means a pharmacist may be able to substitute Yusimry for Humira without first contacting the prescriber, depending on state pharmacy laws.

Yusimry is available in two formulations:

• Standard formulation: 40 mg/0.8 mL in a single-dose prefilled pen (Yusimry Pen) or a single-dose prefilled glass syringe.
• High-concentration formulation: 40 mg/0.4 mL and 80 mg/0.8 mL in a single-dose prefilled pen (Yusimry Pen). The high-concentration formulation delivers the same 40 mg dose in half the liquid volume.

Normally, your immune system defends your body against diseases by fighting harmful bacteria or viruses. However, in autoimmune disorders, the immune system becomes overactive and mistakenly attacks its own tissues, leading to symptoms of the autoimmune condition. Tumor necrosis factor (TNF) is a protein that is involved in causing inflammation. Yusimry is a recombinant human monoclonal antibody that binds to TNF-alpha and blocks its action, helping to reduce pain, inflammation, and skin symptoms.

Yusimry is FDA-approved to treat:

• Rheumatoid arthritis that is moderately to severely active in adults. It can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs).
• Juvenile idiopathic arthritis that is moderately to severely active and polyarticular, in children 2 years of age and older. It can be used alone or with methotrexate.
• Psoriatic arthritis that is active, in adults. It can be used alone or with non-biologic DMARDs.
• Ankylosing spondylitis that is active, in adults.
• Crohn's disease that is moderately to severely active, in adults and children 6 years of age and older.
• Ulcerative colitis that is moderately to severely active, in adults. It is not known whether Yusimry is effective in people who stopped responding to or could not tolerate TNF-blocker medicines.
• Plaque psoriasis that is moderate to severe and chronic, in adults who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light alone or with pills), and when other systemic therapies are medically less appropriate.
• Hidradenitis suppurativa that is moderate to severe, in people 12 years of age and older.
• Uveitis (non-infectious intermediate, posterior, and panuveitis) in adults and children 2 years of age and older.

Yusimry does not come in a form that allows weight-based dosing for children who weigh less than 30 kg (66 lbs) with juvenile idiopathic arthritis or uveitis, or less than 40 kg (88 lbs) with Crohn's disease.

Use Yusimry exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Yusimry is injected under the skin (subcutaneous injection) using a prefilled pen or a prefilled syringe.

The dose schedule for Yusimry depends on the condition you are treating and, for children, their weight. Follow your doctor's dosing instructions very carefully.

A healthcare provider will teach you or your caregiver how to inject this medicine properly. Do not inject this medicine if you do not fully understand the instructions for proper use. Ask your doctor or pharmacist if you have any questions.

Do not use this medicine if you have any signs of an infection. Call your doctor for instructions.

Take the pen or prefilled syringe out of the refrigerator 15 to 30 minutes before injecting to allow it to reach room temperature. Do not remove the cap or cover while it is warming up. Do not warm it using heat sources such as hot water or a microwave.

Prepare your injection only when you are ready to give it. Do not use it if the medicine looks cloudy, has changed color, or has particles in it. Yusimry should be clear to slightly opalescent and colorless to slightly yellow. Call your pharmacist for new medicine.

Inject the full amount in the pen or syringe. Choose an injection site on the front of your thighs or your abdomen, except for the 2 in (5 cm) area around the belly button (navel). Rotate the injection site each time you give an injection. Each new injection site should be at least 1.2 in (3 cm) away from the site you used before.

Do not inject into skin that is red, hard, tender, damaged, bruised, or scarred, and do not inject through your clothes.

Your doctor will need to examine you on a regular basis while you are using Yusimry.

Use a pen or prefilled syringe only once, then place it in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

Yusimry affects your immune system. You may get infections more easily, even serious or fatal infections, including tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that spread throughout the body.

Before or during treatment with Yusimry, tell your doctor if you have signs of infection such as fever, chills, aches, tiredness, cough, skin sores, diarrhea, or burning when you urinate.

Your doctor should test you for TB before you start taking Yusimry and monitor you closely for signs and symptoms of TB during treatment, even if your TB test was negative.

Lymphoma and other cancers, some fatal, have been reported in children and teenagers using TNF blockers, including adalimumab products. A rare and usually fatal type of lymphoma called hepatosplenic T-cell lymphoma (HSTCL) has occurred mostly in teenagers and young men with Crohn's disease or ulcerative colitis, most of whom were also taking azathioprine or 6-mercaptopurine.

Before you start using Yusimry, tell your doctor if you have signs of infection such as fever, chills, sweats, muscle aches, tiredness, cough, bloody mucus, skin sores, diarrhea, burning when you urinate, or feeling constantly tired.

Yusimry should only be used in the age groups approved for each condition. Children should be brought up to date with all vaccines, if possible, before starting Yusimry.

Tell your doctor if you have ever had:

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

Tell your doctor where you live and if you have recently traveled or plan to travel. You may be exposed to infections that are common in certain areas of the world.

The needle cover on the Yusimry pen and prefilled syringe is not made from natural rubber latex.

Yusimry may cause a rare type of lymphoma (cancer) of the liver, spleen, and bone marrow that can be fatal. This has occurred mainly in teenagers and young men with Crohn's disease or ulcerative colitis. However, anyone with an inflammatory autoimmune disorder may have a higher risk of lymphoma. Talk with your doctor about your own risk.

Pregnancy

Available studies of adalimumab use during pregnancy do not reliably show a link between adalimumab and major birth defects. Adalimumab passes across the placenta, especially during the third trimester, and may affect your baby's immune system. Tell your doctor if you are pregnant or planning a pregnancy. If you used Yusimry during pregnancy, make sure your baby's doctor knows before your baby receives any vaccines, especially live vaccines.

Breastfeeding

Small amounts of adalimumab have been found in breast milk. The amount a breastfed baby absorbs is expected to be low, and no side effects in breastfed babies have been reported. Talk to your doctor about the best way to feed your baby while using Yusimry.

Get emergency medical help if you have any of these signs of an allergic reaction to Yusimry: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor right away if you have any symptoms of lymphoma:

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

Also call your doctor at once if you have:

• new or worsening psoriasis (raised, silvery flaking of the skin);
• a sore or bump on your skin that does not heal;
• symptoms of sepsis - confusion, chills, severe drowsiness, fast heartbeats, rapid breathing, feeling very ill;
• liver problems, including hepatitis B coming back or autoimmune hepatitis - body aches, tiredness, stomach pain, right-sided upper stomach pain, vomiting, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• lupus-like syndrome - joint pain or swelling, chest pain, shortness of breath, patchy skin color that worsens in sunlight;
• nerve problems - numbness, tingling, dizziness, vision problems, weakness in your arms or legs;
• low blood cell counts - bruising, bleeding, or a fever that does not go away;
• new or worsening heart failure - shortness of breath, swelling of your ankles or feet, sudden weight gain; or
• signs of tuberculosis - fever with ongoing cough, weight loss (fat or muscle).

Older adults may be more likely to develop infections or cancer while using Yusimry.

Common side effects of Yusimry may include:

• headache;
• infections such as cold symptoms, stuffy nose, sinus pain, sneezing, sore throat;
• rash; or
• redness, bruising, itching, or swelling 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 FDA at 1-800-FDA-1088.

Yusimry is available as:

• Yusimry Pen: 40 mg/0.8 mL in a single-dose pen.
• Yusimry Pen (high-concentration): 40 mg/0.4 mL in a single-dose pen.
• Yusimry Pen (high-concentration): 80 mg/0.8 mL in a single-dose pen.
• Yusimry Prefilled Syringe: 40 mg/0.8 mL in a single-dose prefilled glass syringe.

The dose and frequency of Yusimry depend on the condition treated and, for children, body weight. For more information on specific dosing schedules, click the link below.

Use the medicine as soon as you remember, and then go back to your regular injection schedule. Do not use extra medicine to make up for the missed dose.

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

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

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Do not receive a "live" vaccine while using Yusimry. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), and some zoster (shingles) vaccines. Other vaccines can usually be given while you are using Yusimry.

Some drugs should not be used together with Yusimry. Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Yusimry, especially:

• abatacept (Orencia) or anakinra (Kineret), because using them with Yusimry increases the risk of serious infections;
• other TNF blockers, such as certolizumab (Cimzia), etanercept (Enbrel), golimumab (Simponi), or infliximab (Remicade);
• rituximab (Rituxan);
• azathioprine or 6-mercaptopurine (Purinethol); or
• medicines that need careful blood level or effect monitoring, such as warfarin, cyclosporine, or theophylline. Your doctor may need to check these medicines when you start or stop Yusimry.

Avoid the use of live vaccines.

This list is not complete. Other drugs may interact with Yusimry, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.

Store in the refrigerator at 36°F to 46°F (2°C to 8°C).

Store in the original carton until use to protect it from light.

Do not freeze. Do not use Yusimry if it has been frozen, even if it has been thawed.

Storage during traveling:

• If needed, you may store Yusimry at room temperature up to 77°F (25°C) for up to 14 days.
• Keep Yusimry in the original carton to protect it from light.
• Throw away Yusimry if it has been kept at room temperature and not used within 14 days.
• Record the date you first remove the medicine from the refrigerator in the spaces provided on the carton and dose tray.
• Do not store Yusimry in extreme heat or cold.

Active ingredient: adalimumab-aqvh

Inactive ingredients:

• 40 mg/0.8 mL pen and prefilled syringe: glycine, L-histidine, L-histidine hydrochloride monohydrate, polysorbate 80, sodium chloride, and Water for Injection. Sodium hydroxide is added as necessary to adjust the pH.
• 40 mg/0.4 mL and 80 mg/0.8 mL pens (high-concentration): mannitol, polysorbate 80, and Water for Injection.

Yusimry does not contain preservatives or citrate.