CinnoRA®


(Adalimumab)


Overview

CinnoRA® (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 40 mg adalimumab as an active substance. CinnoRA® (adalimumab) is used to treat rheumatoid arthritis, polyarticular juvenile idiopathic arthritis in children who are at least 2 years old, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis, and a chronic skin condition called hidradenitis suppurativa. It is also used to treat Adult Crohn's disease, Pediatric Crohn’s Disease (in pediatric patients 6 years of age and older), ulcerative colitis and uveitis. CinnoRA® (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 in Auto Injector Device- 40 mg/0.8 mL

Indication and Usage

  • Rheumatoid Arthritis

  • CinnoRA® is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis (RA).

  • Polyarticular Juvenile Idiopathic Arthritis

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

  • Psoriatic Arthritis

  •  CinnoRA® is indicated for reducing signs and symptoms, inhibiting the progression of structural damage of active arthritis, and improving physical function in patients with psoriatic arthritis (PsA).

  • Ankylosing Spondylitis

  • CinnoRA®  is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis (AS).

  • Adult Crohn’s Disease

           CinnoRA® 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.

  • Pediatric Crohn’s Disease

        CinnoRA® 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 who have had an inadequate response to conventional therapy.

  • Ulcerative Colitis

         CinnoRA® 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 conventional   therapy.

  • Plaque Psoriasis

         CinnoRA® is indicated for the treatment of adult patients with chronic moderate to severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate.

  • Hidradenitis Suppurativa

         CinnoRA® is indicated for the treatment of moderate to severe hidradenitis suppurativa.

  • Uveitis

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

 

How to Use?

  • CinnoRA® is administered as an injection at your doctor's office, hospital, or clinic. You can use it at home if you were learnt how to use it and by permission of your doctor.
  • This medicine comes with a Patient Information Leaflet. Read it carefully.
  • Make sure you clearly understand and carefully follow your doctor's instructions how to give yourself an injection.
  • Wash your hands with soap and water and use a clean work area to prepare your injection.
  • Remove the syringe from the refrigerator. Leave at room temperature for at least 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 (eg, in a microwave or in hot water).
  • A single-use prefilled syringe is for one injection only. Throw the used syringe away after one use, even if there is still medicine left in it. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.
  • Use CinnoRA® exactly as prescribed by your doctor. Follow the directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended. Use CinnoRA® regularly to get the most benefit.
  • The dose schedule for CinnoRA® is highly variable and depends on the condition you are treating. You may need an injection only every other week. Or you may need up to 2 injections in 1 day for 2 days in a row. Follow your doctor's dosing instructions very carefully.
  • Do not start using CinnoRA® 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 doctor for instructions.
  • CinnoRA® is injected subcutaneously. You may be shown how to use injections at home. Do not self-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 (eg, stomach area, thigh) must be rotated from one injection to the next. Do not inject into areas where the skin is tender, bruised, red, or hard. Avoid areas with scars or stretch marks. If you have psoriasis, try not to inject directly into any raised, red, thick, or scaly skin patches.
  • Each prefilled syringe is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose. Do not use a prefilled syringe if the medicine if it looks cloudy or has particles in it. Call your pharmacist for new medicine.
  • Serious infections or bleeding from an injury may occur during treatment with Adalimumab. Your blood may need to be tested often. Contact your doctor right away if you have signs of infection such as: fever, chills, sore throat, or flu symptoms.
  • If you need surgery, tell the surgeon ahead of time that you are using adalimumab.
  • If you have ever had hepatitis B, you will need frequent blood tests to check your liver function during treatment and for several months after you stop using this medicine. Visit your doctor regularly.

Store in a refrigerator. If you travel with a prefilled syringe, keep it in a small cooler with an ice pack and protect it from light. Do not freeze, and throw away the medicine if it has become frozen.

  • Do not use Adalimumab after the expiration date on the label has passed.
  • Do not shake the prefilled syringe. Vigorous shaking can ruin the medicine.

 

  • How to inject it:

CinnoRA® is available in Auto Injector device, BD Physioject™, for safe subQ injection.

Note: Remember that before injection by BD Physioject™, you should be trained by a doctor, pharmacist or nurse.

  1. What do you need to administer your injection using CinnoRA®?
  • BD Physioject™ Device
  • A skin disinfectant
  • A Sharps container to dispose of your used BD Physioject™.

 

BD Physioject components

 

   What should you do before administering the injection?

  • Wash your hands thoroughly.
  • If CinnoRA® has been stored in the refrigerator, wait until it returns to room temperature before using it.
  • Hold the device by the handling area and check it before use.

   Please note

  • If you notice that BD Physioject™ appears to be damaged, or BD Physioject™ has been dropped, do not use it and dispose of it in the Sharps Container. Use another one or contact your doctor, pharmacist or nurse for assistance and suitable advice.

 

Place BD Physioject™ on a stable horizontal surface.

In what zone should you administer your injection? The preferred injection sites are:

  • upper thighs (area 1),
  • Abdomen (area 2) except around the navel.

Choose a different injection site for each injection Do not inject in an area where the skin is reddened, bruised or abnormal in any way.

How do you administer the injection?

  • Disinfect the surface of your skin at the chosen injection site with a disinfecting swab and let the skin dry.
  • Grasp BD Physioject™ by the Handling Area.
  • Use your other hand to pull out the Cap and discard it.
  • Please note Only remove the cap just before injection.

 

  • With your other hand, gently pinch a sizable cleaned skin area creating a fold on which to position the BD Physioject™ tip.
  • Position the uncapped transparent tip of BD Physioject™ a 90° angle on the skin fold.
  • Push down until you feel the stop-point. Pushing to the stop-point unblocks the Button. 

 

 You are now ready to perform the injection

  • While holding BD Physioject™ firmly against the skin, push the button with your thumb or index finger. Keep the BD Physioject™ in place. The injection will last about 10 seconds.
  • Please note: If the injection is not triggered, release the Button, make sure that BD Physioject™ is pushed firmly against the skin until you feel the stop-point and push harder on the Button.
  • You will hear a click which indicates the start of the injection.
  • Please note: Do not remove BD Physioject™ from the skin before the end of the injection in order to avoid incomplete injection.
  • Monitor the injection through the Transparent Control Zone to make sure that the entire dose is injected.
  • When the movement stops, the injection is completed. Keep holding BD Physioject™ against the skin for a few seconds.
  • Remove BD Physioject™ straight up from the injection site.
  • Release the skin fold.
  • The protective sleeve automatically covers the needle. It is then locked and the needle is protected.
  • Before disposing of BD Physioject™, check visually that there is no liquid left in the syringe, at the bottom of the transparent control zone. If the medication has been incompletely injected, consult your doctor.
  • Please note: To avoid any injury, never try to touch the needle.

How do you ensure the safe disposal of BD Physioject™?

  • Discard the used BD Physioject™ in the Sharps Container as instructed by your doctor, nurse or pharmacist.
  • Please note: Keep the Sharps Container out of the sight and reach of children.

 

What should I know BEFORE treatment?

You should not use CinnoRA® if you are allergic to adalimumab, or if you have an active infection.

Before you start treatment with CinnoRA®, your doctor may perform tests to make sure you do not have tuberculosis or other infections.

Tell your doctor or pharmacist if you have or develop any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances (eg, latex or rubber). Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • if you have 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 your doctor where you live and where you have recently traveled or plan to travel to during treatment.
  • if you have a history of tuberculosis (TB) or a positive TB skin test, if you have ever lived in, recently traveled or plan to travel to an area where TB is common, or if you have been in close contact with someone who has had TB
  • if you have any numbness or tingling or a disease that affects your nervous system (eg, multiple sclerosis [MS], Guillain-Barré syndrome, seizures)
  • if you have 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 (eg, anemia), bone marrow problems, an autoimmune disorder (eg, lupus).
  • if you have a history of liver problems (eg, hepatitis B), liver problems caused by drinking alcohol (alcoholic hepatitis), or hepatitis B virus reactivation when taking Adalimumab or other TNF blockers
  • if you are scheduled to have surgery or any kind of vaccination, or have recently received a vaccine
  • Use in children
  • CinnoRA® should not be given to a child younger than 2 years old (or 6 years old if treating Crohn's disease).
  • Children using CinnoRA® should be current on all childhood immunizations before starting treatment.

What should I know DURING treatment?

  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Hepatitis B testing may be done. A hepatitis B infection may get worse during care.
  • Long-term use may raise your chance of cancer.
  • Very bad infections have been reported with use of this drug. If you have any infection, are taking antibiotics now or in the recent past, or have many infections, talk with your doctor.
  • Talk with your doctor before getting any vaccines. Use with this drug may either raise the chance of an infection or make the vaccine not work as well.
  • If you have heart disease, talk with your doctor.
  • If you have MS (multiple sclerosis) or other nerve disease, talk with your doctor.
  • Check all drugs you are taking with your doctor. This drug may not mix well with some other drugs.
  • Tell dentists, surgeons, and other doctors that you use this drug.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this drug while you are pregnant.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.
  • If you have high blood sugar (diabetes), talk with your doctor. You may be more likely to get infections.

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these side effects persist or become bothersome:

What are some side effects of this drug?

  • You may have more chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu.
  • 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 your doctor immediately if you notice 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, very bad 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 your legs or belly.
  • Chest pain or pressure.
  • Very bad headache.
  • Not 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 your 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.
  • Side effect or health problem is not better or you are feeling worse.

 

This is not a complete list of all side effects that may occur. If you notice any effects that are not listed here, discuss them with your doctor or contact us at OrchidPharmed patient support center

phone number: +982142593

24/7 hotline phone number: +989363094949

Ask your doctor or pharmacist if you don’t understand anything in this list. Do not be alarmed by this list of possible side effects. You may not experience any of them.

What should I do if I miss a dose?

o   Use the medicine as soon as you remember, and then go back to your regular injection schedule.

o   Do not use extra medicine to make up the missed dose. Do not take 2 doses at the same time or extra doses.

o   If it is close to the time for your next dose, skip the missed dose and go back to your normal time.

o   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

    Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

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

    Comment:

    -Women of childbearing potential should be advised to use effective contraception during treatment and for at least 5 months after discontinuation.

     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. Seek further medical advice from your doctor.

Pregnancy and Lactation

Pregnancy

Risk Summary

Limited clinical data are available from the adalimumab Pregnancy Registry. Excluding lost-to-follow-up, data from the registry reports a rate of 5.6% for major birth defects with first trimester use of adalimumab in pregnant women with rheumatoid arthritis (RA), and a rate of 7.8% and 5.5% for major birth defects in the disease-matched and non-diseased comparison groups. Adalimumab is actively transferred across the placenta during the third trimester of pregnancy and may affect immune response in the in-utero exposed infant. In an embryo-fetal perinatal development study conducted in cynomolgus monkeys, no fetal harm or malformations were observed with intravenous administration of adalimumab during organogenesis and later in gestation, at doses that produced exposures up to approximately 373 times the maximum recommended human dose (MRHD) of 40 mg subcutaneous without methotrexate.

The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and miscarriage is 15-20%, respectively.

Clinical Considerations

Fetal/Neonatal adverse reactions

Monoclonal antibodies are increasingly transported across the placenta as pregnancy progresses, with the largest amount transferred during the third trimester. Risks and benefits should be considered prior to administering live or live-attenuated vaccines to infants exposed to adalimumab in utero.

Data

Human Data

In a prospective cohort pregnancy exposure registry conducted in the U.S. and Canada between 2004 and 2013, 74 women with RA treated with adalimumab at least during the first trimester, 80 women with RA not treated with adalimumab and 218 women without RA (non-diseased) were enrolled. Excluding lost-to-follow-up, the rate of major defects in the adalimumab-exposed pregnancies (N=72), disease-matched (N=77), and non-diseased comparison groups (N=201) was 5.6%, 7.8% and 5.5%, respectively.

However, this study cannot definitely establish the absence of any risk because of methodological limitations, including small sample size and non-randomized study design. Data from the Crohn’s disease portion of the study is in the follow-up phase and the analysis is ongoing.

In an independent clinical study conducted in ten pregnant women with inflammatory bowel disease treated with adalimumab, adalimumab concentrations were measured in maternal serum as well as in cord blood (n=10) and infant serum (n=8) on the day of birth. The last dose of adalimumab was given between 1 and 56 days prior to delivery. Adalimumab concentrations were 0.16-19.7 μg/mL in cord blood, 4.28- 17.7 μg/mL in infant serum, and 0-16.1 μg/mL in maternal serum. In all but one case, the cord blood level of adalimumab was higher than the maternal serum level, suggesting adalimumab actively crosses the placenta. In addition, one infant had serum levels at each of the following: 6 weeks (1.94 μg/mL), 7 weeks (1.31 μg/mL), 8 weeks (0.93 μg/mL), and 11 weeks (0.53 μg/mL), suggesting adalimumab can be detected in the serum of infants exposed in utero for at least 3 months from birth.

Animal Data

In an embryo-fetal perinatal development study, pregnant cynomolgus monkeys received adalimumab from gestation days 20 to 97 at doses that produced exposures up to 373 times that achieved with the MRHD without methotrexate (on an AUC basis with maternal IV doses up to 100 mg/kg/week).

Adalimumab did not elicit harm to the fetuses or malformations.

Lactation

Risk Summary

Limited data from case reports in the published literature describe the presence of adalimumab in human milk at infant doses of 0.1% to 1% of the maternal serum level. There are no reports of adverse effects of adalimumab on the breastfed infant and no effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for adalimumab and any potential adverse effects on the breastfed child from adalimumab or from the underlying maternal condition

How Supplied / Storage and Handling

 

  • Store CinnoRA® pre-filled syringes in the refrigerator at 2 to 8 ºC. Do not freeze.
  • Always keep pre-filled syringes in the outer carton in order to protect from light. Do not use CinnoRA® after the expiry date which is stated on the carton and pre-filled syringe.
  •  
  • Keep out of the reach and sight of children

FAQs

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