KidiMab®


(Adalimumab)

Overview

KidiMab® (Adalimumab) works by decreasing a certain protein produced by the immune system and reduces the effects of this substance in the body which can cause inflammation.

It is available as a pre-filled syringe. It contains 20 mg Adalimumab as an active substance. KidiMab® (Adalimumab) is used to treat polyarticular juvenile idiopathic arthritis in children who are at least 2 years old. It is also used to treat Pediatric Crohn’s Disease (in pediatric patients 6 years of age and older). KidiMab® (Adalimumab) can be used for other therapeutic purposes not listed in this medication guide, according to physician discretion.

Dosage Forms and Strengths

Sterile Prefilled Syringe - 20 mg/ 0.4 mL

Indication and Usage

Polyarticular Juvenile Idiopathic Arthritis

is indicated for reducing signs and symptoms of moderately to severely active Polyarticular juvenile idiopathic arthritis (JIA) in patients ages 2 and older.

Pediatric Crohn’s Disease

KidiMab® (Adalimumab) is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active Crohn’s disease that have had an inadequate response to conventional therapy.

Adults:

Rheumatoid Arthritis

Adalimumab is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active Rheumatoid arthritis. Adalimumab can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs).

Psoriatic Arthritis

Adalimumab is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active Psoriatic arthritis. Adalimumab can be used alone or in combination with non-biologic DMARDs.

Ankylosing Spondylitis

Adalimumab is indicated for reducing signs and symptoms in adult patients with active Ankylosing spondylitis.

Adult Crohn’s Disease

Adalimumab is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy. Adalimumab is indicated for reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab.

Ulcerative Colitis

Adalimumab is indicated for inducing and sustaining clinical remission in adult patients with moderately to severely active Ulcerative colitis who have had an inadequate response to immunosuppressants such as corticosteroids, azathioprine or 6-mercaptopurine (6-MP). The effectiveness of adalimumab has not been established in patients who have lost response to or were intolerant to TNF blockers.

Plaque Psoriasis

Adalimumab is indicated for the treatment of adult patients with moderate to severe chronic Plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. Adalimumab should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician

Hidradenitis Suppurativa

Adalimumab is indicated for the treatment of moderate to severe Hidradenitis suppurativa.

Uveitis

Adalimumab is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients

How to Use?

  • KidiMab® is administered as an injection at the doctor's office, hospital, or clinic. KidiMab® can be used at home if the patients or their caregiver have learned how to use it and by permission of a doctor.
  • This medicine comes with a Patient Information Leaflet. It should be read carefully.
  • Make sure you clearly understand and carefully follow your doctor's instructions how to give yourself/ your patient, an injection.
  • Wash your hands with soap and water and use a clean work area to prepare your/ your patients injection.
  • Remove the syringe from the refrigerator. Leave at room temperature for 15- 30 minutes before using. Do NOT remove the needle cover while allowing it to reach room temperature. Do not warm adalimumab in any other way (e.g., in a microwave or hot water).
  • A single-use prefilled syringe is for one injection only. After the first injection, the syringe should be thrown away in a puncture-proof container (disposal of needles and getting a new one can be asked from a pharmacist), even if there is still medicine left in it.

This container should be kept out of the reach of children and pets.

  • KidiMab® should be used exactly as prescribed by the doctor. The directions on your/ your patients’ prescription label should be followed. Using this medicine in larger or smaller amounts or for longer duration is not recommended. KidiMab® should be used regularly to get the most benefit.
  • The dose schedule for KidiMab® is highly variable and depends on the condition the patient’s treatment. The patient may need an injection only every other week or may need up to 2 injections in 1 day for 2 days in a row. The doctor's dosing instructions should be followed very carefully.
  • Do not start using KidiMab® if you have any signs of an infection (fever, chills, night sweats, weight loss, body aches, tiredness, cough with mucus, feeling short of breath, skin sores, stomach pain, diarrhea, pain or burning when you urinate). Call your/ your patients’ doctor for instructions.
  • KidiMab® is injected subcutaneously. You may be shown how to use injections at home. Do not inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.
  • Injection sites within an injection area (stomach area, thigh) must be rotated from one injection to the next. The drug should be injected at a distance of 2.5 cm from the previous injection. Injection into areas where the skin is tender, bruised, red, hard, areas with scars or stretch marks should be avoided. If the patient has psoriasis, injection directly into any raised, red, thick, or scaly skin patches should be avoided.
  • Do not use a prefilled syringe if the medicine looks cloudy or has particles in it. Call CinnaGen patient support center for new medicine.
  • Serious infections or bleeding from an injury may occur during treatment with Adalimumab. The patient blood may need to be tested often. Contact the doctor right away if you/your patient have signs of infection such as: fever, chills, sore throat, or flu symptoms.
  • If you/your patient needs surgery, tell the surgeon ahead of time that you are using adalimumab.
  • If you/your patient have ever had hepatitis B, frequent blood tests are needed to check the liver function during treatment and for several months after stopping the use of this medicine. You/ your patient regularly should be visited by the doctor.
  • The drug should be stored in a refrigerator. If the patient travels with a prefilled syringe, the drug should be kept in a small cooler with an ice pack and must be protected from light. The drug should be kept from freezing, and if the medicine has frozen must be thrown away.
  • Adalimumab should not be used after the expiration date printed on the label.

Do not shake the prefilled syringe. Vigorous shaking can ruin the medicine.

How to inject it:

What do you need to administer your injection using KidiMab®?

  • sterile pre-filled syringe
  • A skin disinfectant
  • A Sharps container for disposal of used pre-filled syringe

What are needed to administer the injection using KidiMab ®?

  • Wash your hand thoroughly.
  • If the drug has been stored in the refrigerator; time should be taken until it returns to room temperature before using.
  • Hold the device by the handling area and check it before use.
  • In what zone injection should be administered?
  • The preferred injection sites are:
  • upper thighs
  • Abdomen except around the navel.
  • A different injection site must be chosen for each injection
  • Injection should not take place in an area where the skin is reddened, bruised or abnormal in any way.
  • How do you administer the injection?
  • Disinfection of the skin surface at chosen site should be done with a disinfecting swab and let dry.
  • Grasp pre-filled syringe by the Handling Area.
  • Use your other hand to pull out the cap and discard it.

    • Notice : The cap must be removed just before injection.

  • With the other hand, gently pinch a sizable cleaned skin area creating a fold on which to position the pre-filled syringe tip.
  • The uncapped transparent tip of pre-filled syringe should be positioned at a 45° angle on the skin fold.
  • The injection can now be performed.

  • Notice: In order to avoid incomplete injection; pre-filled syringe should not be removed from the skin before the end of the injection. The injection should be performed at least within 10 seconds.

  • Before disposal of pre-filled syringe, it should be visually checked that there is no liquid left in the syringe. If the medication has been incompletely injected, consulting a doctor is recommended.

    Notice: To avoid any injury, the needle should never be touched.

  • How do you ensure the safe disposal of a pre-filled syringe?
  • The used pre-filled syringe should be discarded in a Sharps Container as instructed by your doctor, nurse or pharmacist.

Notice: Avoid touching the needle.

What should I know BEFORE treatment?

KidiMab® should not be used if the patient is allergic to Adalimumab, or if has an active infection.

Before starting treatment with KidiMab®, the doctor may perform tests to make sure the patient doesn’t have tuberculosis or other infections.

Tell the doctor or pharmacist if the patient has or develops any medical conditions, especially if any of the following apply to you:

  • If the patient is pregnant, planning to become pregnant, or is breast-feeding
  • if the patient taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • If the patient has allergies to medicines, foods, or other substances (e.g., latex or rubber). Tell the doctor about the allergy and what signs the patient had, like rash; hives; itching; shortness of breath; wheezing; a cough; swelling of the face, lips, tongue, or throat; or any other signs.
  • If the patient has any kind of recent or chronic infections or signs of infection such as: fever, chills, sore throat, or flu symptoms. Some infections are more likely to occur in certain areas of the world. Tell the doctor where the patient lives and where has recently traveled or plan to travel to during treatment.
  • If the patient has a history of tuberculosis (TB) or a positive TB skin test, if the patient has ever lived in, recently traveled or plan to travel to an area where TB is common, or if the patient has been in close contact with someone who has had TB.
  • If the patient has any numbness or tingling or a disease that affects the nervous system (e.g., multiple sclerosis [MS], Guillain-Barre syndrome, seizures)
  • If the patient has a history of congestive heart failure, lymphoma (cancer of the lymph nodes), melanoma (a tumor that usually affects the skin) or other past or present cancers, a blood problem (e.g., anemia), bone marrow problems, an autoimmune disorder (e.g., lupus).
  • If the patient has a history of liver problems (e.g., hepatitis B), liver problems caused by drinking alcohol (alcoholic hepatitis), or hepatitis B virus reactivation when taking Adalimumab or other TNF blockers.
  • If the patient is scheduled to have a surgery or any vaccination, or have recently received a vaccine.

Note:

KidiMab® should not be given to a child younger than 2 years old (or 6 years old if treating Crohn's disease).

Children using KidiMab® should be current on all childhood immunizations before starting treatment.

What should I know DURING treatment?

  • Keep a list of all of your drugs (prescription, natural products, vitamins, OTC) and give it to the doctor.
  • Hepatitis B testing may be done. A hepatitis B infection may get worse during care.
  • Long-term use of adalimumab may raise the chance of cancer.
  • Serious infections have been reported with use of this drug. If you have any infection, or you are taking antibiotics now (or in the recent past), or have many infections, informed your doctor.
  • It is recommended that pediatric patients, if possible, be brought up to date with all immunizations in agreement with current immunization guidelines before initiating Adalimumab therapy.
  • Before receiving any vaccines, consulting with a doctor is necessary. Use of this drug may either raise the chance of an infection or make the vaccine not work as well.
  • Talk with your/ your patients doctor in presence of heart disease.
  • Inform your/ your patients’ doctor in case of sun burn or other skin disorders.
  • If the patient has MS or other nervous system disease, inform the doctor.
  • Any drugs taken should be checked by a doctor. Adalimumab may have interactions with some other drugs.
  • Informed the other physicians, dentist or surgeon about adalimumab usage.
  • Informed the doctor in the case of pregnancy or planning on getting pregnant. Benefits and risks of this drug during pregnancy should be discussed with a doctor.
  • Tell the doctor that the patient is breast- feeding. Any risk to the baby during the breastfeeding period should be discussed with a doctor.
  • If burning, numbness, or tingling feeling that is not normal; change in eyesight; dizziness; seizures; or weakness in arms or legs is observed, call the doctor immediately. (Use of Adalimumab, rarely, has been associated with rare cases of new onset or exacerbation of clinical symptoms of central and peripheral nervous system demyelinating disease.)
  • Informed the doctor if the patient has a high blood sugar or diabetes. It can increase infection susceptibility.

 

Adverse Reactions / Side Effects

All medicines may cause side effects, but many people have no, or minor, side effects. If any of these side effects persist or become bothersome, check it with the doctor:

What are some side effects of this drug?

  • Getting an infection becomes more susceptible. Hands must be washed more often. People with infections, colds, or flu must be avoided.
  • Headache.
  • Flu-like signs. These include headache, weakness, fever, shakes, aches, pains, and sweating. Mild pain drugs may help.
  • Irritation where the shot is given.

Tell the doctor immediately if the patient notices the following:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of infection. These include a fever of 100.5°F (38°C) or higher, chills, awful sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, wound that will not heal, or anal itching or pain.
  • Trouble breathing.
  • Swelling in legs or belly.
  • Chest pain or pressure.
  • Very bad headache.
  • Not being able to eat.
  • Very bad belly pain.
  • Very upset stomach or throwing up.
  • Feeling very tired or weak.
  • Very bad back pain.
  • Numbness or tingling in hands or feet.
  • Any bruising or bleeding.
  • Dark urine or yellow skin or eyes.
  • Night sweats.
  • A big weight loss.
  • Fever that does not go away.
  • Any rash.
  • Red scaly patches or bumps that are pus filled.
  • Side effect or health problem doesn’t get better or is getting worse.

Contact Patient Support

If you notice any effects that are not listed above, discuss them with your doctor or click here to see Orchid Pharmed Patient Support Center contact details.

What should I do if I miss a dose?

  • Use the missed dose as soon as you remember and then go back to the regular schedules.
  • If the time for the next dose is close, the missed dose should be skipped and normal time should continue.
  • Two/ extra doses must never be taken at the same time.
  • Do not change the dose or stop this drug. If you have any question, contact your doctor for instructions right away.

Pregnancy and Lactation

Pregnancy

Inform the doctor if the patient is pregnant or planning a pregnancy before starting/ using any medicine.

This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus.

Nursing mothers

This drug is minimally excreted into breast milk and poorly absorbed by the infant.

A decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. More medical advice can be obtained from a doctor.

How Supplied / Storage and Handling

  • Keep KidiMab® out of the reach and sight of children.
  • refrigerator at 2 to 8 ºC.
  • Do not freeze the drug.
  • Always keep pre-filled syringes in the outer carton in order to protect from light.
Do not use KidiMab® after its expiry date.
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