Hadlima

What is Hadlima?

Hadlima is a medicine called a Tumor Necrosis Factor (TNF) blocker. Hadlima is 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.
  • moderate to severe polyarticular juvenile idiopathic arthritis (JIA) in children 4 years and older. Hadlima can be used alone, with methotrexate, or with certain other medicines.
  • psoriatic arthritis (PsA) in adults. Hadlima 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).

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

Hadlima is a medicine that affects your immune system. Hadlima can lower the ability of your immune system to fight infections. 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.
• Your doctor should check you closely for signs and symptoms of TB during treatment with Hadlima.

You should not start taking Hadlima if you have any kind of infection unless your doctor says it is okay.

Before starting Hadlima, tell your doctor if you:

• think you have an infection or have symptoms of infection such as:
  • fever, sweats, or chills
  • warm, red, or painful skin or sores on
  • muscle aches your body
  • cough
  • diarrhea or stomach pain
  • shortness of breath
  • burning when you urinate or urinate
  • blood in phlegm more often than normal
  • feel very tired
  • weight loss
• are being treated for an infection
• get a lot of infections or have infections that keep coming back
• have diabetes
• have TB, or have been in close contact with someone with TB
• were born in, lived in, or traveled to countries where there is more risk for getting TB. Ask your doctor if you are not sure.
• live or have lived in certain parts of the country (such as the Ohio and Mississippi River valleys) where there is an increased risk for getting certain kinds of fungal infections (histoplasmosis, coccidioidomycosis, or blastomycosis). These infections may happen or become more severe if you use Hadlima. Ask your doctor if you do not know if you have lived in an area where these infections are common.
• have or have had hepatitis B
• use the medicine Orencia (abatacept), Kineret (anakinra), Rituxan (rituximab), IMURAN (azathioprine), or Purinethol (6–mercaptopurine, 6-MP).
• are scheduled to have major surgery

After starting Hadlima, call your doctor right away if you have an infection, or any sign of an infection.
Hadlima can make you more likely to get infections or make any infection that you may have worse.

Cancer

• For children and adults taking Tumor Necrosis Factor (TNF)-blockers, including Hadlima, the chances of getting cancer may increase.
• There have been cases of unusual cancers in children, teenagers, and young adults using TNF-blockers.
• People with rheumatoid arthritis (RA), especially more serious RA, may have a higher chance for getting a kind of cancer called lymphoma.
• If you use TNF blockers including Hadlima, your chance of getting two types of skin cancer may increase (basal cell cancer and squamous cell cancer of the skin). These types of cancer are generally not life-threatening if treated. Tell your doctor if you have a bump or open sore that doesn’t heal.
• Some people receiving TNF blockers including Hadlima developed a rare type of cancer called hepatosplenic T-cell lymphoma. This type of cancer often results in death. Most of these people were male teenagers or young men. Also, most people were being treated for Crohn’s disease or ulcerative colitis with another medicine called Imuran (azathioprine) or Purinethol (6-mercaptopurine, 6–MP).

What should I tell my healthcare provider before using Hadlima?

Hadlima may not be right for you. Before starting Hadlima, tell your doctor about all of your health conditions, including if you:

• have an infection. See “What is the most important information I should know about Hadlima?”
• 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 had heart failure.
• have recently received or are scheduled to receive a vaccine. You may receive vaccines, except for live vaccines while using Hadlima. Children should be brought up to date with all vaccines before starting Hadlima.
• are allergic to Hadlima or to any of its ingredients. See the end of this Medication Guide for a list of ingredients in Hadlima.
• are pregnant or plan to become pregnant, breastfeeding or plan to breastfeed. You and your doctor should decide if you should take Hadlima while you are pregnant or breastfeeding.
• have a baby and you were using Hadlima during your pregnancy. Tell your baby’s doctor before your baby receives any vaccines.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Especially tell your doctor if you use:

• Orencia (abatacept), Kineret (anakinra), Remicade (infliximab), Enbrel (etanercept), Cimzia (certolizumab pegol) or Simponi (golimumab), because you should not use Hadlima while you are also using one of these medicines.
• Rituxan (rituximab). Your doctor may not want to give you Hadlima if you have received Rituxan (rituximab) recently.
• Imuran (azathioprine) or Purinethol (6–mercaptopurine, 6-MP).

Keep a list of your medicines with you to show your doctor and pharmacist each time you get a new medicine.

How should I use Hadlima?

• Hadlima is given by an injection under the skin. Your doctor will tell you how often to take an injection of Hadlima. This is based on your condition to be treated. Do not inject Hadlima 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 Hadlima.
• Make sure you have been shown how to inject Hadlima before you do it yourself. You can call your doctor or 1-877-888-4231 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 Hadlima.
• Do not try to inject Hadlima 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 Hadlima at home, you should receive training on the right way to prepare and inject Hadlima.
• Do not miss any doses of Hadlima unless your doctor says it is okay. If you forget to take Hadlima, 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 Hadlima, call your doctor or pharmacist.
• If you take more Hadlima than you were told to take, call your doctor.

What are the possible side effects of Hadlima?

Hadlima can cause serious side effects, including: See “What is the most important information I should know about Hadlima?”

• 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 Hadlima and during treatment with Hadlima. Even if your TB test is negative your doctor should carefully monitor you for TB infections while you are taking Hadlima. People who had a negative TB skin test before receiving adalimumab have developed active TB. Tell your doctor if you have any of the following symptoms while taking or after taking Hadlima:
  • cough that does not go away
  • weight loss
  • low grade fever
  • loss of body fat and muscle (wasting)
• 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 use Hadlima. Your doctor should do blood tests before you start treatment, while you are using Hadlima, and for several months after you stop treatment with Hadlima. Tell your doctor if you have any of the following symptoms of a possible hepatitis B infection:
  • muscle aches
  • clay-colored bowel movements
  • feel very tired
  • fever
  • dark urine
  • chills
  • skin or eyes look yellow
  • stomach discomfort
  • little or no appetite
  • skin rash
  • vomiting
• Allergic reactions. Allergic reactions can happen in people who use Hadlima. Call your doctor or get medical help right away if you have any of these symptoms of a serious allergic reaction:
  • hives
  • swelling of your face, eyes, lips or mouth
  • trouble breathing
• 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.
• New heart failure or worsening of heart failure you already have. Call your doctor right away if you get new worsening symptoms of heart failure while taking Hadlima, including:
  • shortness of breath
  • swelling of your ankles or feet
  • 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 a rash on your cheeks or arms that gets worse in the sun. Symptoms may improve when you stop Hadlima.
• 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:
  • feel very tired
  • skin or eyes look yellow
  • poor appetite or vomiting
  • pain on the right side of your stomach (abdomen)
• Psoriasis. Some people using adalimumab products had new psoriasis or worsening of psoriasis they already had. Tell your doctor if you develop red scaly patches or raised bumps that are filled with pus. Your doctor may decide to stop your treatment with Hadlima.

Call your doctor or get medical care right away if you develop any of the above symptoms. Your treatment with Hadlima may be stopped.

Common side effects with Hadlima include:

• 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.
• upper respiratory infections (including sinus infections)
• headaches
• rash

These are not all the possible side effects with Hadlima. Tell your doctor if you have any side effect that bothers you or that does not go away. Ask your doctor or pharmacist for more information.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

General information about the safe and effective use of Hadlima

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Hadlima for a condition for which it was not prescribed. Do not give Hadlima to other people, even if they have the same condition. It may harm them.
This Medication Guide summarizes the most important information about Hadlima. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Hadlima that is written for health professionals.

For more information call Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. at 1-877-888-4231.

How should I store Hadlima?

• Store Hadlima in the refrigerator at 36ºF to 46ºF (2ºC to 8ºC). Store Hadlima in the original carton until use to protect it from light.
• Do not freeze Hadlima. Do not use Hadlima if frozen, even if it has been thawed.
• Refrigerated Hadlima may be used until the expiration date printed on the Hadlima carton, dose pack, autoinjector or prefilled syringe. Do not use Hadlima after the expiration date.
• If needed, for example when you are traveling, you may also store Hadlima at room temperature up to 77°F (25°C) for up to 14 days. Store Hadlima in the original carton until use to protect it from light.
• Throw away Hadlima if it has been kept at room temperature and not been used within 14 days.
• Record the date you first remove Hadlima from the refrigerator in the spaces provided on the carton and dose pack.
• Do not store Hadlima in extreme heat or cold.
• The solution should be clear and colorless to pale brown. Do not use an autoinjector or prefilled syringe if the liquid is cloudy, discolored, or has flakes or particles in it.
• Do not drop or crush Hadlima. The prefilled syringe is glass.

Keep Hadlima, injection supplies, and all other medicines out of the reach of children.

What are the ingredients in Hadlima?

Active ingredient: adalimumab-bwwd

Hadlima PushTouch 40 mg/0.8 mL, Hadlima 40 mg/0.8 mL prefilled syringe:

Inactive ingredients: citric acid monohydrate, L-histidine, L-histidine hydrochloride monohydrate, polysorbate 20, sodium citrate dihydrate, sorbitol, and Water for Injection, USP.

Instructions for use for Hadlima

Hadlima (HAD-lee-mah)

(adalimumab-bwwd)

40 mg/0.8 mL

Single Dose Prefilled Syringe

For subcutaneous (under the skin) use only

Do not try to inject Hadlima yourself until you have been shown the right way to give an injection and have read and understand this Instructions for Use. If your doctor decides that you or a caregiver may be able to give your injection of Hadlima at home, you should receive training on the right way to prepare and inject Hadlima. It is important that you read, understand, and follow these instructions so that you inject Hadlima the right way. Call your healthcare provider if you or your caregiver have any questions about the right way to inject Hadlima.

To help you remember when to inject Hadlima, you can mark your calendar ahead of time.

The following instructions are for preparing and giving 1 dose of Hadlima using a single dose prefilled syringe. Read this Instructions for Use before you start using Hadlima.

What is included in this Instructions for Use

• Your single dose prefilled syringe
• Caring for your syringe
• How to inject with your syringe
• How should I throw away (dispose of) the used prefilled syringes?
• Extra tips for injecting Hadlima
• Frequently asked questions (FAQs)

Your single dose prefilled syringe:

After you push the plunger all the way down, the needle will be covered automatically (retract) to help prevent needle stick injury.

Caring for your syringe
How should I store Hadlima?

• Store Hadlima in the refrigerator between 36°F to 46°F (2°C to 8°C).
• Do not freeze Hadlima. Do not use Hadlima if frozen, even if it has been thawed.
• Refrigerated Hadlima may be used until the expiration date printed on the Hadlima carton, dose pack, or prefilled syringe. Do not use Hadlima after the expiration date.
• If needed, for example when you are traveling, you may also store Hadlima at room temperature up to 77°F (25°C) for up to 14 days. Throw away Hadlima if it has been kept at room temperature and not been used within 14 days.
• Store Hadlima in the original carton until you use it to protect it from sunlight and indoor light.
• Record the date you first remove Hadlima from the refrigerator in the spaces provided on the carton and dose pack.
• Do not store Hadlima in extreme heat or cold.
• Do not drop or crush Hadlima. The prefilled syringe is glass.

Keep Hadlima, injection supplies, and all other medicines out of the reach of children.

• Use each syringe only 1 time. Do not reuse a syringe.
• Throw away your used syringe in a sharps container.

If you have any questions, visit our website at Hadlima.COM or call the hotline at 1-800­ 555-5555.

How to inject with your syringe

Step 1: Remove your prefilled syringe from the refrigerator and wait 15 to 30 minutes

• For a more comfortable injection, you should wait 15 to 30 minutes for the medicine in your prefilled syringe to reach room temperature.
• Do not warm Hadlima in any other way (for example, do not warm it in a microwave or in hot water).

Step 2: Gather supplies

• You will need the following supplies for each injection of Hadlima.
  Find a clean, flat surface to place the supplies on.
  • 1 Hadlima prefilled syringe
  • 1 alcohol swab (not included in your Hadlima carton)
  • cotton ball or gauze (not included in your Hadlima carton)
  • puncture-resistant sharps disposal container for Hadlima prefilled syringe disposal (not included in your Hadlima carton). See “How should I throw away (dispose of) the used prefilled syringes?” section at the end of this Instructions for Use.

If you do not have all the supplies you need to give yourself an injection, go to a pharmacy or call your pharmacist.

Step 3: Inspect the medicine and check the expiration date

• You should always check the expiration date to make sure Hadlima prefilled syringe has not expired. Do not use if the expiration date has passed.
• Do not use Hadlima if:
  • the prefilled syringe is frozen or has been left in sunlight and indoor light.
  • it has been kept at room temperature for longer than 14 days or Hadlima has been stored above 77ºF (25 ºC).
  • See the “Caring for your syringe” and “Frequently asked questions (FAQs)” sections of this Instructions for Use.
• The solution should be clear and colorless to pale brown. Do not use the prefilled syringe if the liquid is cloudy, discolored, or has flakes or particles in it.
• You may see one or more air bubbles in the body with window, and that is okay. There is no reason to remove it.
• Do not remove the needle cap until Step 5.

Step 4: Choose the injection site and clean the skin

• Wash and dry your hands.
• Choose an injection site on your body. The recommended injection site is the front of the thigh or lower abdomen (belly), but not the area 2 inches (5 cm) around your belly button (naval).
• Choose a different site each time you give yourself an injection.
• Do not inject into areas where the skin is tender, bruised, red, scaly or hard. Avoid areas with scars or stretch marks. If you have psoriasis, you should not inject directly into areas with psoriasis plaques.
• Wipe your skin at the injection site with an alcohol swab in a circular motion. Let the skin dry before injecting.
• Do not touch this area again before giving the injection.

Step 5: Pull off the needle cap

• Carefully pull off the needle cap straight off to remove it from the prefilled syringe.
• Throw away the needle cap.
• Do not touch the needle with your fingers or let the needle touch anything.

Step 6: Pinch the skin and insert the needle

• Gently pinch your skin at the injection site and insert the needle all the way into your skin at about a 45 degree angle.

Step 7: Push the plunger all the way

• Hold the syringe and press the plunger all the way down until the syringe is empty.
• Then take your thumb off the plunger to let the needle retract into the body of the syringe.

Step 8: Remove the syringe

• Pull the syringe away from your skin at the same angle that you pushed it in.
• Make sure that the needle has retracted.
  • Not sure if you received your dose? Call 1-800-555-5555.

Step 9: How should I throw away (dispose of) the used prefilled syringes?

• Put your used syringes in an FDA-cleared sharps disposal container right away after use.
• Do not throw away (dispose of) syringes in your household trash.
• If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:
  • made of a heavy-duty plastic,
  • can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
  • upright and stable during use,
  • leak-resistant, and
  • properly labeled to warn of hazardous waste inside the container.
• When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of sharps disposal containers. There may be state or local laws about how you should throw away used syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA’s website at: http://www.fda.gov/safesharpsdisposal.
• Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.

Extra tips for injecting Hadlima

Now that you understand the basics of giving yourself an injection, here are some extra tips to help you.

Choose a fatty area for injection

• Fatty areas, like your stomach, are generally the best injection sites. Fatty areas are easier to pinch and are good for inserting the needle correctly.

Use a different injection site every time

• When choosing an injection site, select an area that has not recently been used to avoid soreness and bruises.

Finalize your injection

• After the injection is complete, you can use a cotton ball or gauze to cover the injection site if there is a little bleeding.

Frequently asked questions (FAQs)

If you have questions, read through these FAQs to learn more. If you still have any questions call 1-800-555-5555.

What should I do if:

My syringe is out of the refrigerator for more than 30 minutes

• It is okay to leave your syringe out for up to 14 days before injecting, as long as it is kept away from sunlight and indoor light. If your syringe has been at room temperature for more than 14 days, call 1-800-555-5555.

The medicine in my syringe is not clear, colorless to pale brown, free of particles, or is expired

• If the medicine in your syringe is not clear, colorless to pale brown, or free of particles, do not use it. If it is expired, do not use it. Get a new syringe. Call 1-800-555-5555.

I see air bubbles in my syringe

• It is normal to see small air bubbles in your syringe. There is no reason to remove them.

I took off my needle cap before I was ready to inject

• Do not put the needle cap back on. This could bend or damage the needle. You might accidentally stick yourself or waste the medicine. Call 1-800-555-5555.

I dropped my syringe

• If you dropped your syringe with the cap on, it is okay to use the syringe. If you dropped your syringe with the cap off, do not use it. The needle might be dirty or damaged. Call 1-800-555-5555.

The syringe is damaged or broken

• Do not use a damaged syringe. Get a new syringe. Call 1-800-555-5555.

The needle never retracted

• If the needle never retracted into the body, the plunger was not pushed all the way down. Press the plunger harder to activate the shield. If you still have trouble, call 1-800-555­-5555.

I am not sure I received my full dose

• You received your full dose if:
  • The plunger was pushed all the way down
  • The needle retracted into the shield
  • All of the medicine went into your skin and did not leak out. (If you see a drop, that is okay)
• If you are still not sure, call 1-800-555-5555.

My sharps container is full

• Call 1-800-555-5555 when your sharps container is full. We will help you dispose of it.

I do not have a sharps container

• If you do not have a sharps container, call 1-800-555-5555. We can give you a container.