Hadlima (Adalimumab)

Warnings and Precautions

You may not be able to fight an infection as well if you take this medication. There is a possibility that this effect can lead to very serious (possibly fatal) infections (such as fungal infections, bacterial infections, including tuberculosis). Please tell your doctor about your medical history, especially past/recent/current infections. In addition, you should tell your doctor if you have been exposed to a person with tuberculosis or if you have lived in an area where certain fungal infections are common (such as coccidioidomycosis or histoplasmosis).

Patients who experience fungal infections, can use medications like Jublia to help mitigate symptoms.

This drug should be used only under the guidance of your doctor if you have tuberculosis (TB) infection. You will be prescribed treatment for TB before using adalimumab if you have been diagnosed with TB.

If you have diabetes and are using insulin, please inform your health practitioner so they can properly asses you.

Cancer (such as lymphoma, skin cancer) can occur (especially in children/teens/young adults) due to this medication or to your medical condition. Consult your doctor about the risks and benefits of treatment. If you develop symptoms like a fever that won’t go away, lumps or growths that don’t disappear, swollen glands, weight loss that isn’t explained, or night sweats, call your doctor right away.

Whether you are allergic to adalimumab, adalimumab products, or any other allergies, tell your doctor before using it. There is a possibility that this product contains inactive ingredients (such as natural rubber/latex), which can cause allergic reactions.

Especially if you are currently/recently/repeatedly infected with hepatitis B, tuberculosis, histoplasmosis, or have a blood/bone marrow problem (such as low platelets and red/white blood cells), please tell your doctor. There are certain brain/nervous disorders (such as multiple sclerosis, Guillain-Barre syndrome), cancer, heart disease (especially heart failure), and lupus, among other conditions.

You may be more likely to get infections if you take adalimumab or your current infections may get worse if you take it. Avoid spreading infectious diseases (chickenpox, COVID-19, measles, flu). If you have been exposed to an infection or would like more information, speak with your doctor.

Before having any immunizations or vaccinations, inform your doctor that you are taking adalimumab. People who have recently received live vaccines (such as flu vaccines inhaled through the nose) should be avoided.

Hadlima Side Effects

Your body may become accustomed to the medication over time so the following side effects may improve. If your symptoms continue or worsen, contact your healthcare provider as soon as possible.

Common Side Effects

• Approximately 20% of injection sites are reacted to
• There were 17 percent of cases of upper respiratory tract infection
• Twelve percent of people report headaches
• 12% of people have rashes
• 11 % of patients have sinus inflammation
• Accidents cause ten percent of injuries
• There was a 9 percent chance of nausea
• Infections of the urinary tract or bladder (8%)

Other Side Effects

• High cholesterol
• High blood pressure
• Back pain
• Stomach pain
• Hair loss
• Blood in the urine
• Flu-like symptoms

Serious Side Effects

Any of the following symptoms should be reported to your healthcare provider immediately.

• Fibrosis, coughing, weight loss, aches, dark urine, chills, and vomiting are signs of a severe infection
• Fever that doesn’t go away, easy bruising or bleeding, and pale skin are all symptoms of low blood cell counts.
• Signsof a severe allergic reaction, which include: a rash, hives, difficulty breathing, and swelling of your face, eyes, lips, or mouth.
• Shortness of breath, legs begin to swell (as well as your ankles or feet), irregular heartbeat, fatigue, and sudden weight gain are symptoms of heart failure.
• There are several symptoms of liver problems, including tiredness, vomiting, yellow skin or whites of the eyes, and stomach discomfort.

Drug Interactions

Certain medications or supplements may interact with Hadlima (adalimumab). Please inform your prescriber if you are currently taking any medications or supplements (including prescription medications such as Crestor or Ibrance, over-the-counter medications, vitamins, or dietary supplements). The following list does not include all possible drug interactions with Hadlima (adalimumab). Below are only the generic names of each medication.

This medicine should not be used with any of the following medicines, but it may be necessary in some cases. The dosage or frequency of one or both medicines may need to be changed if both medicines are prescribed together.

• Abatacept
• Vaccine against Adenovirus
• Anakinra
• Vaccine against Bacillus of Calmette and Guerin
• Vaccine against Cholera
• Tetravalent Dengue Vaccine
• Infliximab
• Vaccine against influenza
• Vaccine against measles
• Vaccine against the Mumps Virus
• Vaccine against poliovirus
• Rilonacept
• Vaccine against Rotavirus
• Vaccine against Rubella Virus
• Vaccine against smallpox
• Tofacitinib
• Vaccination against Typhoid
• Vaccine against varicella virus
• Vaccine against yellow fever
• Vaccine against Zoster

Hadlima Forms And Strengths

Hadlima is available to purchase in prefilled syringe as well as the PushTouch Autoinjector.

Prefilled Syringe: 40 mg/0.8 mL

Adalimumab is contained in each 0.8 mL of preservative-free, sterile solution. This product contains the following nonmedicinal ingredients: citric acid monohydrate, sodium citrate dihydrate, L-histidine, L-histidine hydrochloride monohydrate, sorbitol and polysorbate 20.

The mechanism of prefilled syringes are found in many medications such as, Saxenda and Victoza.

PushTouch Autoinjector: 40 mg/0.8 mL

Preservative-free, sterile solutions containing adalimumab contain 0.8 mL. Nonmedicinal ingredients in this product include citric acid monohydrate, sodium citrate dihydrate, L-histidine, L-histidine hydrochloride monohydrate, sorbitol, and polysorbate 20.

How to Use Hadlima

Follow the directions on the label or those prescribed by your doctor when using Hadlima Prefilled Syringe (Subcutaneous). It is recommended to use at most the recommended amount or for a more extended period.

Read all medication guides and instructions on your prescription label that you receive with your medicine. There may be times when your doctor changes your dose. Follow the directions on the medicine strictly.

Injections of adalimumab are administered under the skin. Your prescriber can teach you how to use this medicine properly. Injecting twice into the same place is not recommended.

Only prepare an injection when you are ready to administer it. Contact your pharmacist immediately if the medicine looks cloudy, has changed colors, or contains particles. When you have questions about how to use an injection, speak with your doctor or pharmacist.

Children and teenagers are given doses based on their weight. Weight gain or loss may cause your child’s dose to change.

It may be easier for you to get serious or fatal infections. Medical tests will be required frequently.

The doctor will test you to ensure you do not have tuberculosis or any other infection before you use adalimumab. Before and during adalimumab treatment, your blood will be tested.

If you require further assistance on using Hadlima, feel free to contact us and we can set you with a free pharmacy consultation with one of our licensed pharmacists.

Overdose

If you think you or someone else overdosed on Hadlima, call your doctor or the Poison Control Center. If someone collapses or isn’t breathing after taking Hadlima call 911.

Missed Dose

Follow your doctor’s instructions exactly when taking this medication. In the event that you miss a dose, administer it as soon as possible and continue with your regular schedule. Continuing your regular dosing schedule is the best course of action if you have missed a dose. To make up for a missed dose, do not take a double dose. Contact your doctor or pharmacist for advice if you are unsure what to do after missing a dose.

Storage

Do not freeze this medicine; keep it in its original container in the refrigerator. Keep away from light. When traveling with your medicine, follow all instructions carefully. Heat and cold should be avoided.

Let it reach room temperature during the first 30 minutes after taking the medicine. Microwaves, hot water, or sunlight should not be used to warm the medicine.

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

Needles and syringes should be used sparingly. Dispose of them according to state or local laws in a puncture-proof “sharps” container. Pets and children should not have access to this product.