Medication Guide

Instructions for Use

Prescribing Information

WHAT IS HADLIMA?: HADLIMA is a prescription medicine used to reduce the signs and symptoms of: Moderate to severe rheumatoid arthritis (RA) in adults. HADLIMA can be used alone, with methotrexate, or with certain other medicines. HADLIMA may prevent further damage to your bones and joints and may help your ability to perform daily activities. Moderate to severe polyarticular juvenile idiopathic arthritis (JIA) in children 2 years of age and older. HADLIMA can be used alone or with methotrexate.

IMPORTANT SAFETY INFORMATION: What is the most important information I should know about HADLIMA?
You should discuss the potential benefits and risks of HADLIMA with your doctor. HADLIMA is a tumor necrosis factor (TNF) blocker medicine that can lower the ability of your immune system to fight infections. You should not start taking HADLIMA if you have any kind of infection unless your doctor says it is okay. Serious infections have happened in people taking HADLIMA. These serious infections include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some people have died from these infections. Your doctor should test you for TB before starting HADLIMA, and check you closely for signs and symptoms of TB during treatment with HADLIMA, even if your TB test was negative. If your doctor feels you are at risk, you may be treated with medicine for TB.

WHAT IS HADLIMA?

HADLIMA is a prescription medicine used to reduce the signs and symptoms of: Moderate to severe rheumatoid arthritis (RA) in adults. HADLIMA can be used alone, with methotrexate, or with certain other medicines. HADLIMA may prevent further damage to your bones and joints and may help your ability to perform daily activities. Moderate to severe polyarticular juvenile idiopathic arthritis (JIA) in children 2 years of age and older. HADLIMA can be used alone or with methotrexate.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about HADLIMA?
You should discuss the potential benefits and risks of HADLIMA with your doctor. HADLIMA is a tumor necrosis factor (TNF) blocker medicine that can lower the ability of your immune system to fight infections. You should not start taking HADLIMA if you have any kind of infection unless your doctor says it is okay. Serious infections have happened in people taking HADLIMA. These serious infections include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some people have died from these infections. Your doctor should test you for TB before starting HADLIMA, and check you closely for signs and symptoms of TB during treatment with HADLIMA, even if your TB test was negative. If your doctor feels you are at risk, you may be treated with medicine for TB.

Dedicated Support

Our patient support program commits to always putting YOU first

Dedicated Nurse Coaches
Injection support
Additional educational resources
Co-pay assistance^‡

If you prefer to sign up on the phone, call 1-833-4HADLIMA to sign up and then speak to a dedicated Nurse Coach.

With HADLIMA For You, you can:

Talk with dedicated Nurse Coaches who will help answer questions you may have

You will talk to the same Nurse Coach each time so you have someone in your corner throughout your treatment journey. They are trained and certified in nurse coaching, so they can answer your questions about HADLIMA, device functionality, and treatment support.

Nurse Coaches are paid by Organon.

Access self-injection guidance

We provide self-injection guidance to ensure you are well equipped with the knowledge and skills necessary to use either device for HADLIMA.

To see how to use the HADLIMA™ PushTouch™ Autoinjector, scroll down to watch the Instructions For Use video or click here.

Pay as little as $0 for your medication with financial support^‡

Our financial and co-pay assistance has been developed to address the costs you may incur during your treatment journey.

Access tips for traveling with HADLIMA

There are a few steps to follow for smooth travel with HADLIMA. HADLIMA For You outlines helpful tips that go into greater detail about how to travel with your medication.

Understand how to work with a specialty pharmacy

You may be new to working with a specialty pharmacy, so we are here to answer questions you may have about the process.

Receive a complimentary sharps container

For your convenience, you can request a complimentary sharps container to properly dispose of your devices.

Watch step-by-step injection directions

Tips for traveling with your medication

Fill out your travel ID card with necessary information
Place alcohol swabs and other needed supplies in your travel case for sterile injections
When traveling, remember to dispose of used devices safely and according to local regulations
If you remove HADLIMA from the refrigerator to travel, it can remain at room temperature up to a maximum of 77°F (25 °C) for up to 14 days, with protection from light

You may be eligible for savings on your
prescription for HADLIMA^†

^† The HADLIMA For You - Savings Program may help save on the cost of treatment. Eligible, commercially insured patients may be able to receive HADLIMA for as little as $0 a month, every month. Not all patients are eligible to use the multi-use savings coupon. Certain restrictions apply. Please see Terms and Conditions.

Save on HADLIMA

*Not all patients are eligible to use the Co-pay savings card. Certain restrictions apply.
^‡ For eligible patients only.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about HADLIMA?

You should discuss the potential benefits and risks of HADLIMA with your doctor. HADLIMA is a tumor necrosis factor (TNF) blocker medicine that can lower the ability of your immune system to fight infections. You should not start taking HADLIMA if you have any kind of infection unless your doctor says it is okay.
Serious infections have happened in people taking adalimumab products. These serious infections include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some people have died from these infections. Your doctor should test you for TB before starting HADLIMA, and check you closely for signs and symptoms of TB during treatment with HADLIMA, even if your TB test was negative. If your doctor feels you are at risk, you may be treated with medicine for TB.
Cancer. For children and adults taking TNF blockers, including HADLIMA, the chance of getting lymphoma or other cancers may increase. There have been cases of unusual cancers in children, teenagers, and young adults using TNF blockers. Some people have developed a rare type of cancer called hepatosplenic T-cell lymphoma. This type of cancer often results in death. If using TNF blockers, including HADLIMA, your chance of getting 2 types of skin cancer (basal cell and squamous cell) may increase. These types are generally not life threatening if treated; tell your doctor if you have a bump or open sore that does not heal.

What should I tell my doctor BEFORE starting HADLIMA?

Tell your doctor about all of your health conditions, including if you:
- Have an infection, are being treated for infection, or have symptoms of an infection
- Get a lot of infections or infections that keep coming back
- Have diabetes
- Have TB or have been in close contact with someone with TB, or were born in, lived in, or traveled where there is more risk for getting TB
- Live or have lived in an area (such as the Ohio and Mississippi River valleys) where there is an increased risk for getting certain kinds of fungal infections, such as histoplasmosis, coccidioidomycosis, or blastomycosis. These infections may happen or become more severe if you use HADLIMA. Ask your doctor if you are unsure if you have lived in these areas.
- Have or have had hepatitis B
- Are scheduled for major surgery
- Have or have had cancer
- Have numbness or tingling or a nervous system disease, such as multiple sclerosis or Guillain-Barré syndrome
- Have or had heart failure
- Have recently received or are scheduled to receive a vaccine. HADLIMA patients may receive vaccines, except for live vaccines. Children should be brought up to date on all vaccines before starting HADLIMA.
- Are allergic to HADLIMA or any of its ingredients
- Are pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed
- Have a baby and were using HADLIMA during your pregnancy. Tell your baby’s doctor before your baby receives any vaccines.
Also tell your doctor about all the medicines you take. You should not take HADLIMA with ORENCIA® (abatacept), KINERET® (anakinra), REMICADE® (infliximab), ENBREL® (etanercept), CIMZIA® (certolizumab pegol), or SIMPONI® (golimumab). Tell your doctor if you have ever used RITUXAN® (rituximab), IMURAN® (azathioprine), or PURINETHOL® (mercaptopurine, 6-MP).

What should I watch for after starting HADLIMA?

HADLIMA can cause serious side effects, including:
- Serious infections. These include TB and infections caused by viruses, fungi, or bacteria. Symptoms related to TB include a cough, low-grade fever, weight loss, or loss of body fat and muscle.
- Hepatitis B infection in carriers of the virus. Symptoms include muscle aches, feeling very tired, dark urine, skin or eyes that look yellow, little or no appetite, vomiting, clay-colored bowel movements, fever, chills, stomach discomfort, and skin rash.
- Allergic reactions. Symptoms of a serious allergic reaction include hives, trouble breathing, and swelling of your face, eyes, lips, or mouth.
- Nervous system problems. Signs and symptoms include numbness or tingling, problems with your vision, weakness in your arms or legs, and dizziness.
- Blood problems (decreased blood cells that help fight infections or stop bleeding). Symptoms include a fever that does not go away, bruising or bleeding very easily, or looking very pale.
- Heart failure (new or worsening). Symptoms include shortness of breath, swelling of your ankles or feet, and sudden weight gain.
- Immune reactions including a lupus-like syndrome. Symptoms include chest discomfort or pain that does not go away, shortness of breath, joint pain, or rash on your cheeks or arms that gets worse in the sun.
- Liver problems. Symptoms include feeling very tired, skin or eyes that look yellow, poor appetite or vomiting, and pain on the right side of your stomach (abdomen). These problems can lead to liver failure and death.
- Psoriasis (new or worsening). Symptoms include red scaly patches or raised bumps that are filled with pus.
Call your doctor or get medical care right away if you develop any of the above symptoms.
Common side effects of HADLIMA include injection site reactions (pain, redness, rash, swelling, itching, or bruising), upper respiratory infections (sinus infections), headaches, rash, and nausea. These are not all of the possible side effects with HADLIMA. Tell your doctor if you have any side effect that bothers you or that does not go away.
Remember, tell your doctor right away if you have an infection or symptoms of an infection, including:
- Fever, sweats, or chills
- Muscle aches
- Cough
- Shortness of breath
- Blood in phlegm
- Weight loss
- Warm, red, or painful skin or sores on your body
- Diarrhea or stomach pain
- Burning when you urinate
- Urinating more often than normal
- Feeling very tired
HADLIMA is given by injection under the skin.
This is the most important information to know about HADLIMA. For more information, talk to your health care provider.
Please read the Medication Guide for HADLIMA, including the information about serious infections and cancers, and discuss it with your doctor. The Instructions for Use and Physician Prescribing Information also are available.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

WHAT IS HADLIMA?

HADLIMA is a prescription medicine used:
- To reduce the signs and symptoms of:
  - Moderate to severe rheumatoid arthritis (RA) in adults. HADLIMA can be used alone, with methotrexate, or with certain other medicines. HADLIMA may prevent further damage to your bones and joints and may help your ability to perform daily activities.
  - Moderate to severe polyarticular juvenile idiopathic arthritis (JIA) in children 2 years of age and older. HADLIMA can be used alone or with methotrexate.
  - Psoriatic arthritis (PsA) in adults. HADLIMA can be used alone or with certain other medicines. HADLIMA may prevent further damage to your bones and joints and may help your ability to perform daily activities.
  - Ankylosing spondylitis (AS) in adults.
  - Moderate to severe hidradenitis suppurativa (HS) in adults.
- To treat moderate to severe Crohn’s disease (CD) in adults and children 6 years of age and older.
- To treat moderate to severe ulcerative colitis (UC) in adults. 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 plaque psoriasis (Ps) in adults who are ready for systemic therapy or phototherapy, and are under the care of a doctor who will decide if other systemic therapies are less appropriate.
- To treat non-infectious intermediate (middle part of the eye), posterior (back of the eye), and panuveitis (all parts of the eye) in adult patients.