Simlandi

Pronunciation: sim-LAN-dee
Generic name: adalimumab-ryvk
Dosage form: single-dose autoinjector (40 mg/0.4 mL)
Drug class: TNF alfa inhibitors

Medically reviewed by Melisa Puckey, BPharm. Last updated on Feb 26, 2024.

What is Simlandi?

Simlandi (adalimumab-ryvk) is a biosimilar of Humira used to reduce pain, inflammation, and skin symptoms in autoimmune conditions plaque psoriasis, Crohn's disease, ulcerative colitis, rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, hidradenitis suppurativa, and uveitis in certain patients.

Simlandi is a TNF alfa inhibitor and one of the interchangeable biosimilars to Humira. Biosimilars are biologic medicines that are a very close copy to the original product made by another company. An interchangeable biosimilar has undergone an additional Interchangeability Study, meaning that patients can be confident in the safety and effectiveness of the interchangeable biosimilar product, just as they would be for the FDA-approved original product, in this case, Humira. Being an interchangeable biosimilar means Simlandi can automatically be substituted by a pharmacist for Humira, with individual state laws controlling how and whether physicians will be notified.

Simlandi is used to treat chronic autoimmune conditions. Normally, your immune system defends your body against diseases by fighting harmful bacteria or viruses. However, in autoimmune disorders, the immune system becomes hyperactive 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. Sinlandi is a TNF blocker that inhibits TNF, helping to reduce pain, inflammation, and skin symptoms.

What is Simlandi used for?

Simlandi is an FDA-approved medicine to be used for:

• rheumatoid arthritis (moderate to severe) in adults to reduce the signs and symptoms of RA slow the progression of structural damage, and to improve physical function.
• juvenile idiopathic arthritis (moderate to severe polyarticular) for children 2 years and older, to reduce the signs and symptoms of moderately to severely active polyarticular JIA.
• psoriatic arthritis in adults to be used to reduce the signs and symptoms of psoriatic arthritis and slow the progression of structural damage, and to improve physical function.
• ankylosing spondylitis in adults to reduce signs and symptoms.
• hidradenitis suppurativa (moderate to severe) in adults.
• Crohn’s disease (moderate to severe) in adults and children 6 years of age and older.
• ulcerative colitis (moderate to severe) in adults. It is not known if Simlandi products are effective in people who stopped responding to or could not tolerate TNF-blocker medicines.
• plaque psoriasis (chronic and moderate to severe) 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).
• uveitis (UV) that is non-infectious intermediate, posterior, and panuveitis, for adult patients.

Simlandi side effects

Common Simlandi side effects

Common side effects of Simlandi may include headache, cold symptoms such as stuffy nose, sinus pain, sneezing, sore throat; rash; or redness, bruising, itching, or swelling where the injection was given.

Serious Simlandi side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Simlandi: 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 - 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; 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 Simlandi.

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

Warnings

Simlandi affects your immune system. You may get infections more easily, even serious or fatal infections.

Before or during treatment with Simlandi, 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 tuberculosis (TB) before starting to take Simlandi and also monitor you closely for signs and symptoms of TB during treatment.

The chances of getting cancer may be increased for children and adults taking TNF-blockers.

Do not take Simlandi if are allergic to the active ingredient adalimumab or to any of the inactive ingredients.

Before taking this medicine

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

Simlandi should only be used in age groups for the specific conditions that Simlandi is FDA-approved to treat. Children using Simlandi should be current on all childhood immunizations before starting treatment.

Tell your doctor if you have ever had:

• tuberculosis (or if anyone in your household has tuberculosis);
• a chronic infection;
• cancer;
• hepatitis B (Simlandi 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;
• an allergy to latex rubber;
• if you are scheduled to have major surgery; or
• if you have 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.

Simlandi 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

It is not known whether Simlandi will harm an unborn baby. Tell your doctor if you are pregnant or planning a pregnancy. Make sure any doctor caring for your newborn baby knows if you used Simlandi while you were pregnant, and especially before your baby receives any vaccines.

Breastfeeding

It may not be safe to breastfeed a baby while you are using Simlandi. Ask your doctor about any risks and the best way to feed your baby while on this medicine.

How should I use Simlandi?

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

Simlandi is injected under the skin (subcutaneous injection) using an autoinjector or a prefilled syringe.

The dose schedule for Simlandi will depend on the severity and the condition that you are treating. Follow your doctor's dosing instructions very carefully.

A healthcare provider will teach you how to properly use Simlandi by yourself. Do not use 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.

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. Call your pharmacist for new medicine.

Leave the autoinjector or prefilled syringe at room temperature 68°F to 77°F (20°C to 25°C) for 15 to 30 minutes to allow it to warm up. Do not warm the Prefilled Syringe using heat sources such as hot water or a microwave.

Choose an injection site. You may inject into the front of your thighs, your abdomen except for the 2 in (5 cm) around the belly button (navel). Rotate the injection site each time you give an injection. Each new injection site should be at least 1 inch (3 cm) away from the injection site you used before.

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

Simlandi affects your immune system so you may get infections more easily, even serious or fatal infections. Your doctor will need to examine you on a regular basis.

Use a needle and syringe only once and then place them 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.

Simlandi Dosing information

The dose and frequency of Simlandi given is dependent on age, severity, and condition treated. For more information on specific dosing schedules click the link below.

Simlandi is available as:

• 40 mg/0.4 mL single-dose autoinjector

Related/similar drugs

Entyvio, Otezla, Sotyktu, Cimzia, Stelara, prednisone, naproxen, methotrexate, triamcinolone ophthalmic, dexamethasone

What happens if I miss a dose?

If you forget to take your dose, 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 your medicine call your doctor or pharmacist.

What happens if I overdose?

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

What should I avoid while using Simlandi?

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 Simlandi. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), or zoster (shingles).

What other drugs will affect Simlandi?

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

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

Avoid the use of live vaccines.

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

Ingredients

Active ingredient: adalimumab-ryvk)

Inactive ingredients: polysorbate 80, sodium chloride, sucrose, and Water for Injection. Sodium hydroxide and hydrochloric acid are added as necessary to adjust pH..

Storage

• Store this medicine in its original carton in a refrigerator at 36°F to 46°F (2°C to 8°C).
• Do not freeze. If you are traveling, carefully follow all patient instructions for storing your medicine during travel.
• Throw away if it has become frozen.
• Avoid extreme heat or cold.
• When traveling, Simlandi may be stored at room temperature up to a maximum of 77°F (25°C) for a period of up to 14 days, with protection from light. This medicine should be discarded if not used within the 14-day period. Record the date when
• the medicine is first removed from the refrigerator on the carton and dose pack.

Manufacturer

Simlandi is manufactured by Alvotech USA Inc., Leesburg, VA 20175

Simlandi Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for Simlandi.

Humira interchangeable products

Interchangeable biosimilar products can be dispensed by a pharmacist without the intervention of the prescriber of the reference product.

Pharmacy laws for biosimilar prescribing may vary by state.

Humira biosimilar products

Biosimilar products can only be dispensed in place of the reference product if the healthcare provider specifically prescribes the biosimilar product by name.

Pharmacy laws for biosimilar prescribing may vary by state

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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