EXEMPTIA 40 Prefilled Syringe(Pfs) 0.8ml
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Introduction About EXEMPTIA 40 PREFILLED SYRINGE(PFS)
EXEMPTIA 40 PREFILLED SYRINGE(PFS) contains Adalimumab which belongs to the group of medicines called a Disease modifying antirheumatic drugs (DMARDs). It is used to manage severe joint pain and inflammation (Ex. rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, enthesitis-related arthritis, psoriatic arthritis). It can also be used to manage other bone conditions such as ankylosing spondylitis (back pain) and axial spondyloarthritis (pain in bones of your head, neck, back and chest).
It also helps in managing auto-immune conditions such as plaque psoriasis (dry, itchy, scaly patches on the skin), hidradenitis suppurativa (painful skin condition causing abscess and scarring), inflammatory bowel disease (such as Crohn’s disease and Ulcerative colitis) and eye inflammation (non-infective uveitis).
Before receiving EXEMPTIA 40 PREFILLED SYRINGE(PFS), inform your doctor if you have any lung, liver, kidney or heart problems. You must also inform your doctor if you have any breathing problems (COPD), have an habit of smoking, recently received any vaccination, recently visited some one who has a serious infection or live in an infection prone as a precaution.
EXEMPTIA 40 PREFILLED SYRINGE(PFS) is strictly not recommended for use in patients with an active infection (Ex. tuberculosis) or heart failure. Inform your doctor before EXEMPTIA 40 PREFILLED SYRINGE(PFS) is administered to you if you are pregnant, think you may be pregnant or breastfeeding.
The most common side effects of receiving EXEMPTIA 40 PREFILLED SYRINGE(PFS) are pain, redness, inflammation and swelling at the site of injection, nausea, vomiting, headache, increased infections, skin rashes, tingling and numbness of skin, brittle nails, hair loss, high blood sugar levels, shortness of breath and fast heart rate. Consult your doctor if any of these side effect worsens.
Uses Of EXEMPTIA 40 PREFILLED SYRINGE(PFS)
It is used to manage:
- severe joint pain and inflammation (rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, enthesitis-related arthritis, psoriatic arthritis)
- back pain (Ankylosing spondylitis), neck pain and pain in bones of your head, back and chest (axial spondyloarthritis).
- plaque psoriasis (dry, itchy, scaly patches on the skin)
- hidradenitis suppurativa (painful skin condition causing abscess and scarring)
- inflammatory bowel disease (such as Crohn’s disease and Ulcerative colitis)
- eye inflammation (non-infective uveitis)
How EXEMPTIA 40 PREFILLED SYRINGE(PFS) Works
EXEMPTIA 40 PREFILLED SYRINGE(PFS) is a monoclonal antibody which acts by suppressing the overactivity of your immune system. It reduces the activity of certain proteins (TNF-alpha) in the body that causes abnormal immune responses, pain and inflammation.
Therefore, it manages and manages joint pain and inflammation, back pain, neck pain, inflammatory bowel diseases, skin conditions and eye conditions caused due to abnormal immune response.
How to use EXEMPTIA 40 PREFILLED SYRINGE(PFS)
EXEMPTIA 40 PREFILLED SYRINGE(PFS) will be given to you by a doctor or a nurse beneath the skin (subcutaneously). It can also be self-administered by the patient if instructed by the doctor. Carefully follow the instructions advised by your doctor in case of self-administration.
Your doctor will decide the correct dose and duration of therapy for you depending upon your age, body weight and health condition.
Side Effects Of EXEMPTIA 40 PREFILLED SYRINGE(PFS)
Common
- injection site reactions (including pain, swelling, redness or itching)
- increased infections (including skin infections, flu, gut infections, UTI, reproductive tract infections, oral infections, ear infections)
- respiratory tract infections (including cold, runny nose, sinus infection, pneumonia)
- nausea, vomiting
- headache, stomach pain, indigestion, bloating, heart burn, acid reflux
- skin rashes, bruising, skin inflammation, increased sweating
- musculoskeletal pain
- fungal infections, joint infections
- benign tumours, skin cancer
- allergic reactions (including skin itching, allergies, hay fever)
- dehydration, mood swings (including depression), anxiety
- difficulty in sleeping, migraine
- tingling or numbness of body parts
- vision disturbances, eye/eyelid inflammation or swelling
- vertigo (spinning sensation)
- fast heart rate, high blood pressure
- flushing, haematoma (collection of blood outside of blood vessels)
- asthma, shortness of breath
- sicca syndrome (including dry eyes and dry mouth)
- brittle nails, hair loss
- bloody urine
- chest pain, oedema (swelling), fever
- increased bleeding or bruising
- low RBC, WBC and platelet counts
- high blood lipid and uric acid levels
- low blood sodium, calcium, potassium, phosphorus levels in blood
- high blood sugar levels
Uncommon
- opportunistic infections (Ex. tuberculosis)
- neurological infections (Ex. viral meningitis)
- inflammation and infection of the large intestine
- cancers (lymph cancer, skin cancer)
- autoimmune conditions
- inflammation of blood vessels
- tremor, nerve pain
- stroke, problems in hearing
- shortness of breath or ankle swelling
- fluid collection in lungs, blood clot in lungs
- difficulty in swallowing
- gallbladder stones or inflammation
- night sweats, sleep disturbances
- impotence
- increased bilirubin levels
Rare
- multiple sclerosis
- nerve disorders, scarring of the lung
- hepatitis or relapse of hepatitis B infection
Contact your doctor immediately if you experience any of the following side effects after receiving EXEMPTIA 40 PREFILLED SYRINGE(PFS):
- severe allergic reaction (such as skin rash, itching, swelling of the face, eyes, lips, tongue, throat, chest tightness, wheezing, dizziness)
- signs of infections (such as fever, wounds, feeling tired or dental problem)
- tuberculosis (cough that does not go away, weight loss, lack of energy, mild fever)
- severe infection in the blood (sepsis)
- signs of nerve damage (such as vision changes, weakness in your arms or legs or numbness or tingling in any part of your body)
- worsening symptoms of heart failure (such as shortness of breath or swelling of your feet)
- fever that does not go away, easy bruising or bleeding, pale skin
- changes in your skin, new lesion formation on the skin, skin discoloration or redness
- lupus-like syndrome (such as persistent unexplained rash, fever with joint pain and tiredness)
- shortness of breath, and swollen feet
How To Manage Side Effects
Headache
Rest and relax. Keep yourself hydrated by drinking plenty of fluids such as water or electrolytes. Applying a pain-relieving balm on your forehead can be beneficial. Do not consume excessive alcohol, as it could aggravate your headache. Consult your doctor if your headache worsens.
Injection Site Reactions
Place an ice pack on the injected site. Do not move the affected area frequently. If the symptom worsens, consult your doctor.
Nausea And Vomiting
Stick to simple meals and avoid oil rich or spicy foods. Consult your doctor if nausea worsens.
Warning & Precautions
Pregnancy
Monitoring requiredEXEMPTIA 40 PREFILLED SYRINGE(PFS) should be used in pregnant women only if considered necessary by the physician. Therefore, inform your doctor before receiving it. Women of childbearing age must use a suitable contraceptive method to avoid pregnancy while undergoing therapy with this medicine and until 5 months after the last dose.
Mothers who received EXEMPTIA 40 PREFILLED SYRINGE(PFS) during their pregnancy must inform about this medicine to their baby’s doctor after the baby is born. This will help your baby’s doctor to analyse your baby’s immune system and schedule vaccination according to your baby health status.
Breastfeeding
Use with CautionEXEMPTIA 40 PREFILLED SYRINGE(PFS) should be used with caution in breastfeeding women. Therefore, consult your doctor before receiving it.
Driving and Using Machines
Use with CautionEXEMPTIA 40 PREFILLED SYRINGE(PFS) may cause vision disturbances and spinning sensation. Therefore, do not drive or operate any heavy tools or machines if your ability is affected by this medicine.
Alcohol
Consult your doctorAvoid consumption of alcohol before receiving EXEMPTIA 40 PREFILLED SYRINGE(PFS).
Kidney
Use with CautionEXEMPTIA 40 PREFILLED SYRINGE(PFS) should be used with caution in patients with kidney problems. Therefore, inform your doctor before receiving it.
Liver
Use with CautionEXEMPTIA 40 PREFILLED SYRINGE(PFS) should be used with caution in patients with active liver infection (hepatitis B virus infection). Therefore, inform your doctor before receiving it.
Allergy
ContraindicatedInform your doctor before receiving EXEMPTIA 40 PREFILLED SYRINGE(PFS) if you are allergic to Adalimumab.
Lungs
Consult your doctorEXEMPTIA 40 PREFILLED SYRINGE(PFS) is not recommended for use in patients with active tuberculosis. It should be used with caution in patients with other lung diseases (such as COPD). Therefore, inform your doctor before receiving it.
Heart Disease
Consult your doctorEXEMPTIA 40 PREFILLED SYRINGE(PFS) is not recommended for use in patients with moderate to severe heart failure. It should be used with caution in patients who have a previous history of serious heart condition. Therefore, inform your doctor before receiving it.
Use In Pediatrics
Use with CautionEXEMPTIA 40 PREFILLED SYRINGE(PFS) should be used with caution in children and adolescents (aged below 18 years). Proper dose adjustments and careful monitoring are required in such patients.
Use In Geriatrics
Use with CautionEXEMPTIA 40 PREFILLED SYRINGE(PFS) should be used with caution in elderly patients. Therefore, consult your doctor before receiving it. Proper dose adjustments and careful monitoring are required in such patients.
Others
EXEMPTIA 40 PREFILLED SYRINGE(PFS) is not recommended for use if you:
- have serious infections
- have symptoms of infections (such as fever, wounds, tiredness, dental problems)
Before receiving EXEMPTIA 40 PREFILLED SYRINGE(PFS), inform your doctor if you:
- are living in an infection prone zone
- live in an area where fungal infections are more common
- have recurrent infections or relapse of any previous infection
- have been in close contact with someone who have any serious infection (such as tuberculosis)
- have or develop a demyelinating disease (a disease that damages the myelin sheath (an insulating layer around the nerves), such as multiple sclerosis)
- recently received any vaccination
- have a habit of smoking
Interactions
A. Drug - Drug interactions:
Before receiving EXEMPTIA 40 PREFILLED SYRINGE(PFS), inform your doctor if you are taking any of the following medicines:
- Other medicines used in the management of joint pain (such as azathioprine, anakinra and abatacept)
- 6-Mercaptopurine (a medicine used to manage cancer)
Overdosage:
EXEMPTIA 40 PREFILLED SYRINGE(PFS) will be given to you only by a doctor or nurse in a hospital, and so it is unlikely to receive an overdose. However, contact your doctor immediately if you experience breathing difficulties, dizziness or symptoms of low blood pressure or muscle stiffness.
Synopsis
| Drug | : | Adalimumab |
| Pharmacological Category | : | TNF-alpha inhibitors |
| Therapeutic Indication | : | Pain relief |
| Dosage Forms | : | Injection, Prefilled Syringe |
More Information
- Keep EXEMPTIA 40 PREFILLED SYRINGE(PFS) out of reach of children
- Store EXEMPTIA 40 PREFILLED SYRINGE(PFS) at room temperature
FAQs About EXEMPTIA 40 PREFILLED SYRINGE(PFS)
Q: What is EXEMPTIA 40 PREFILLED SYRINGE(PFS) used for?
A: EXEMPTIA 40 PREFILLED SYRINGE(PFS) is used to manage severe joint pain and inflammation (Ex. rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, enthesitis-related arthritis, psoriatic arthritis). It can also be used to manage other bone conditions such as ankylosing spondylitis (back pain) and axial spondyloarthritis (pain in bones of your head, neck, back and chest).
It also helps in managing auto-immune conditions such as plaque psoriasis (dry, itchy, scaly patches on the skin), hidradenitis suppurativa (painful skin condition causing abscess and scarring), inflammatory bowel disease (such as Crohn’s disease and Ulcerative colitis) and eye inflammation (non-infective uveitis).
Q: What are the side effects of EXEMPTIA 40 PREFILLED SYRINGE(PFS)?
A: The most common side effects of receiving EXEMPTIA 40 PREFILLED SYRINGE(PFS) are pain, redness, inflammation and swelling at the site of injection, nausea, vomiting, headache, increased infections, skin rashes, tingling and numbness of skin, brittle nails, hair loss, high blood sugar levels, shortness of breath and fast heart rate. Consult your doctor if any of these side effect worsens.
Q: Can a person receiving EXEMPTIA 40 PREFILLED SYRINGE(PFS) breastfeed?
A: EXEMPTIA 40 PREFILLED SYRINGE(PFS) should be used with caution in breastfeeding women. Therefore, consult your doctor before receiving it.
Q: Is EXEMPTIA 40 PREFILLED SYRINGE(PFS) safe?
A: EXEMPTIA 40 PREFILLED SYRINGE(PFS) is safe at doses prescribed by the physician.
Q: How EXEMPTIA 40 PREFILLED SYRINGE(PFS) works?
A: EXEMPTIA 40 PREFILLED SYRINGE(PFS) is a monoclonal antibody which acts by suppressing the overactivity of your immune system. It reduces the activity of certain proteins (TNF-alpha) in the body that causes abnormal immune responses, pain and inflammation.
Q: Will EXEMPTIA 40 PREFILLED SYRINGE(PFS) increases the risk of infection?
A: Yes. EXEMPTIA 40 PREFILLED SYRINGE(PFS) can increase the risk of infections. It includes skin infections, flu, gut infections, UTI, reproductive tract infections, respiratory tract infections, oral infections, ear infections, fungal infections, meningitis, tuberculosis, or hepatitis. This is because EXEMPTIA 40 PREFILLED SYRINGE(PFS) works by suppressing your immune system. Therefore, consult your doctor immediately if you experience any signs of infection.
Q: Can I take other medicines for joint pain while receiving EXEMPTIA 40 PREFILLED SYRINGE(PFS)?
A: EXEMPTIA 40 PREFILLED SYRINGE(PFS) can be taken together with other joint pain medications, steroids, and pain-relieving medicines (such as methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, injectable gold preparations, prednisolone, indomethacin, etc.). However, consult your doctor before taking them together.
Q: What type of drug is EXEMPTIA 40 PREFILLED SYRINGE(PFS)?
A: EXEMPTIA 40 PREFILLED SYRINGE(PFS) contains adalimumab which belongs to Disease modifying antirheumatic drugs (DMARDs). It works by reducing the activity of certain proteins (TNF-alpha) in the body that causes abnormal immune responses, pain and inflammation.
References
1. KD. Tripathi. Antirheumatoid and antigout drugs. Immunosuppressant drugs Essentials of Medical Pharmacology. 7th Edition. 2013. Page – 212 & 884.
2. Carter R. Ellis; Chaudhary Ehtsham Azmat. Adalimumab. StatPearls. NIH. National Library of Medicine. National Center for Biotechnology Information. PMC. PubMed Central. December 2022. [Accessed on 27th March 2023] https://www.ncbi.nlm.nih.gov/books/NBK557889/
3. AbbVie Biotechnology GmbH. Humira 40 mg solution for injection in pre-filled syringe. Adalimumab. European Medicines Compendium. [Revised in April 2021]. [Accessed on 27th March 2023] https://www.medicines.org.uk/emc/files/pil.2150.pdf
4. AbbVie Inc. HUMIRA® (adalimumab) injection, for subcutaneous use. U. S. Food and Drug Administration. [Revised in August 2018]. [Accessed on 27th March 2023] https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125057s410lbl.pdf
5. Adalimumab. NHS. UK. [Revised in March 2022]. [Accessed on 27th March 2023] https://www.nhs.uk/medicines/adalimumab/side-effects-of-adalimumab/
6. Amgen Canada Inc. PrAMGEVITA®. adalimumab injection. [Revised in July 2021]. [Accessed on 27th March 2023] https://www.amgen.ca/-/media/Themes/CorporateAffairs/amgen-ca/amgen-ca/documents/products/en/en-2021-07-09-amgevita-PIL.pdf
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