Abrilada (adalimumab-afzb) (Generic Adalimumab Injection)
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Adalimumab injection use may impair your resistance to infection and raise your risk of getting a serious infection, such as a significant fungal, bacterial, or viral infection that could spread throughout the body. These infections may require medical treatment and may result in death. Inform your doctor if you frequently contract any kind of infection, currently possess one, or suspect one. This includes transient infections (like cold sores), mild infections (such open cuts or sores), and persistent, chronic illnesses.Also let your doctor know if you have previously had an immune system disorder or if you currently reside in an area where severe fungal infections are more prevalent, such as the Ohio or Mississippi river valleys. If you’re unsure whether certain infections are more prevalent where you live, ask your doctor. Inform your doctor if you are taking any of the following medicines that lower immune system activity: abatacept (Orencia), anakinra (Kineret), certolizumab (Cimzia), etanercept (Enbrel), golimumab (Simponi), infliximab (Remicade), methotrexate (Otrexup, Rasuvo, Trexall), rituximab (Rit (Prelone).
Throughout and after your treatment, your doctor will keep an eye out for any infections. Call your doctor right away if you suffer any of the following symptoms before your treatment starts, while it is being administered, or just afterward: Sweating, a sore throat, a cough that produces bloody mucus, a fever, excessive exhaustion, diarrhoea, stomach pain, warm, red, or painful skin, painful, difficult, or frequent urination, or other infection-related symptoms.
You might already have hepatitis B (a virus that damages the liver) or tuberculosis (TB; a deadly lung infection), but show no signs of the illnesses. Adalimumab injection in this instance may raise the possibility that your infection will worsen and that you may have symptoms. Your doctor may request a blood test to determine whether you have an inactive hepatitis B infection in addition to performing a skin test to determine whether you have a TB infection. Before you start your adalimumab treatment, your doctor may, if required, give you medication to treat this infection. If you have or have ever had TB, if you have ever lived in or visited a country where TB is prevalent, or if you have ever been around someone who has or has ever had TB, let your doctor know. Call your doctor right once if you have any of the following TB symptoms, or if you start to experience any of them while receiving treatment: the following symptoms: fever, night sweats, muscle loss, weight loss, or a cough. In addition, call your physician right away if you have any of the following hepatitis B symptoms or if any of these symptoms appear during or after treatment: An extreme amount of fatigue, yellowing of the skin or eyes, appetite loss, sickness or vomiting, muscle aches, dark urine, clay-colored bowel motions, a fever, chills, and stomach pain.
Adalimumab injection or comparable drugs caused severe or life-threatening malignancies, including lymphoma, in some kids, teenagers, and young adults (cancer that begins in the cells that fight infection). Adalimumab or comparable drugs caused some male teenagers and young adults to develop hepatosplenic T-cell lymphoma (HSTCL), a highly dangerous cancer that frequently results in death within a short period of time. The majority of those who developed HSTCL were taking adalimumab or a similar medication along with another drug called azathioprine (Imuran) or 6-mercaptopurine to treat ulcerative colitis or Crohn’s disease, conditions in which the body attacks the lining of the digestive tract and causes pain, diarrhoea, weight loss, and fever (Purinethol). If your child has ever had cancer of any kind, let the doctor know. Call your child’s doctor right away if he or she experiences any of the following during treatment: stomach pain, fever, unexplained weight loss, enlarged glands in the neck, underarms, or groyne, or quick bleeding or bruising. The dangers of administering an adalimumab injection to your child should be discussed with their doctor.
When you start therapy with adalimumab injection and after each dose, your doctor or pharmacist will hand you the manufacturer’s patient information leaflet (Medication Guide). If you have any questions, carefully read the material and contact your doctor or pharmacist. The Medication Guide is also available on the manufacturer’s website or the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm).
Discuss the dangers of using adalimumab injection with your doctor.
Why is this medication prescribed?
The following autoimmune illnesses (disorders in which the immune system assaults healthy portions of the body and results in discomfort, swelling, and destruction) can be treated with adalimumab injection, either by itself or in combination with other medications:
- Adults with rheumatoid arthritis, a condition in which the body assaults the joints, might experience pain, swelling, and functional loss in their joints.
- Children 2 years of age and older who have juvenile idiopathic arthritis (JIA), a condition in which the body attacks its own joints, might experience discomfort, swelling, loss of function, and delays in growth and development.
- In adults and children aged 6 and older with Crohn’s disease, the body assaults the lining of the digestive tract, resulting in discomfort, diarrhoea, weight loss, and fever, and the condition does not get better when treated with other drugs,
- When other drugs and therapies failed to work or were intolerable in individuals with ulcerative colitis (a disorder that causes swelling and ulcers in the lining of the colon [large intestine] and rectum),
- In people with ankylosing spondylitis, the body assaults the joints in the spine and other parts of the body, resulting in discomfort and joint degeneration.
- Adults with psoriatic arthritis (a disorder that causes joint discomfort, swelling, and skin scales),
- Adults with hidradenitis suppurativa, a skin condition that results in bumps that resemble pimples in the armpits, groyne, and anal region,
- Adults with uveitis (swelling and inflammation of several eye regions),
- Adults with chronic plaque psoriasis, a skin condition that causes red, scaly patches to appear on certain body parts.
The drug adalimumab injection belongs to the group of drugs known as tumour necrosis factor (TNF) inhibitors. It functions by preventing the body’s production of TNF, a chemical that triggers inflammation.
How should this medicine be used?
Adalimumab injection is available as a solution (liquid) for subcutaneous injection (under the skin). Typically, it is administered once every other week. Your doctor may advise you to inject the medication every two weeks for the first three doses of adalimumab injection to treat Crohn’s disease, hidradenitis suppurativa, or ulcerative colitis, and then once every other week after that. Adalimumab injection is used to treat rheumatoid arthritis, and your doctor may recommend that you administer the medication once a week. Mark the days you are supposed to inject adalimumab on your calendar to assist yourself remember to do so. If there is anything you do not understand about the instructions on your prescription label, contact your doctor or pharmacist to clarify it. Exactly as instructed, administer adalimumab injection. Use only as directed by your doctor, either in the recommended amount or frequency.
Your doctor’s office will be where you get your first adalimumab injection. After that, you have the option of administering the adalimumab injection yourself or by hiring a friend or relative. Read the enclosed written instructions before administering adalimumab injection for the first time. To learn how to inject a medicine, ask your doctor or pharmacist to demonstrate it to you or the person doing the injecting.
Prefilled syringes and dosage pens are available for the adalimumab injection. Only use one syringe or pen per solution, and inject the entire contents of the syringe or pen. Do not inject again, even if there is still some solution in the syringe or pen, after you have once done so. Put used pens and syringes in a container that won’t puncture. How to get rid of the puncture-resistant container should be discussed with your doctor or pharmacist.
If you’re using a prefilled syringe or a dosing pen that has been chilled, set it down on a flat surface, leaving the needle cap on, and let it thaw to room temperature for 15 to 30 minutes before you’re ready to inject the drug. Never attempt to reheat the drug by putting it in a hot water bath, microwave, or any other device.
Avoid dropping or crushing the dosage pens or prefilled syringes. These gadgets could break if they are dropped because they are constructed of glass or contain glass.
Adalimumab injection can be injected anywhere on the front of your thighs or stomach, with the exception of the two inches (5 cm) around your navel. Use a different place for each injection to lessen the possibility of discomfort or redness. Each injection should be administered at least 1 inch (2.5 cm) away from an area that has already been used. Keep a record of the locations where you have administered injections so that you won’t do so there again. Never administer an injection to skin that is irritated, bruised, red, or firm, or that has scars or stretch marks.
Before injecting, always check the adalimumab injection solution. Verify that the liquid is clear and colourless, that the syringe or dosing pen contains the appropriate volume of liquid, and that the expiration date has not past. If a syringe or dosing pen is out-of-date, does not contain the right amount of liquid, is murky, or has flakes in it, do not use it.
Your illness won’t be cured with adalimumab injection, but it might help you manage it. Adalimumab injection should be continued even if you feel OK. Adalimumab injectable usage should not be discontinued without consulting a physician.
Other uses for this medicine
Ask your doctor or pharmacist for more details if you believe this drug should be used for something else.
What special precautions should I follow?
Before using adalimumab injection,
- If you have an allergy to adalimumab injection, any other medications, or any of the chemicals in adalimumab injection, tell your doctor and pharmacist right away. For a list of the ingredients, consult the Medication Guide or speak with your pharmacist. Tell your doctor if you or the person assisting you administer the adalimumab injection have a latex or rubber allergy if you plan to use the prefilled syringe.
- Inform your doctor and pharmacist about all prescription and over-the-counter drugs, vitamins, dietary supplements, and herbal products that you are now taking or intend to use. Mention any of the following drugs as well as the ones in the IMPORTANT WARNING section if you are taking cyclosporine (Gengraf, Neoral, Sandimmune), theophylline (Elixophyllin, Theo 24, or warfarin), or both (Coumadin, Jantoven). Your physician might need to adjust the dosage of your drugs or keep a close eye on you for side effects.
- Tell your doctor if you have or have ever had, in addition to the conditions listed in the IMPORTANT WARNING section, numbness or tingling in any part of your body, any disease that affects your nervous system, such as multiple sclerosis (a condition in which the nerves do not function properly and cause weakness, numbness, loss of muscle coordination, problems with vision, speech, and bladder control), Guillain-Barré syndrome (weakness, tingling, and Inform your doctor if light therapy has been used to treat your psoriasis if you have.
- Inform your doctor if you are expecting, intend to get pregnant, or are nursing a baby. Call your doctor if you become pregnant while receiving an injection of adalimumab.
- Be sure to inform the surgeon or dentist that you are using adalimumab injection if you are having surgery, including dental surgery.
- Avoid getting any shots without first consulting your doctor. Make sure your child has had all the vaccinations necessary for youngsters of his or her age before starting therapy with adalimumab injection if they will be receiving one.
What special dietary instructions should I follow?
Keep eating normally unless your doctor instructs you otherwise.
What should I do if I forget a dose?
If you miss a dosage, administer it as soon as you remember. then administer the subsequent dose on the day prescribed. If the next dose is soon due, skip the missed one and carry on with your regular dosing plan. To make up for a missing dose, do not take a second one.
What side effects can this medication cause?
Adalimumab injectable side effects are possible. If any of these symptoms are severe or do not go away, let your doctor know right once:
- Bruising, discomfort, swelling, or rashes where you administered the adalimumab injection
- Back ache
Some adverse effects can be very harmful. Call your doctor right away or seek emergency care if you notice any of the following symptoms or those noted in the IMPORTANT WARNING section:
- Tingling or numbness
- Difficulties with eyesight
- Leg shakiness
- Chest pain
- Breathing difficulty
- Rash, particularly one that is sensitive to sunlight and appears on the arms or cheeks
- A new joint ache
- Swelling of the lower legs, feet, ankles, or face
- Breathing or swallowing challenges
- Fever, chills, a sore throat, and other symptoms of infection
- Abnormal bleeding or bruising
- Light skin
- Pus-filled lumps or red, scaly spots on the skin
Adults who receive adalimumab injection may have a higher risk of developing skin cancer, lymphoma, and other cancers than adults who do not. You should discuss the dangers of using this drug with your doctor.
Other adverse effects from adalimumab injection are possible. If you experience any strange issues while taking this drug, call your doctor right away.
You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting programme online or by phone if you have a serious side event (1-800-332-1088).
What should I know about storage and disposal of this medication?
Keep this medication tightly closed in the original container and out of the reach of children. Protect it from light and keep it in the refrigerator. In addition, adalimumab injectable may be kept for up to 14 days under darkness and at room temperature (up to 77°F [25°C]). Adalimumab injectable needs to be thrown away after being kept at room temperature for more than 14 days without being used. Avoid freezing it. Any medication that has been frozen should be thrown away.
Unused prescriptions must be disposed of carefully to prevent pets, kids, and other people from ingesting them. You should not, however, dispose of this medication in the toilet. Instead, utilising a medicine take-back programme is the easiest approach to get rid of your medication. To find out about take-back programmes in your area, speak with your pharmacist or the garbage/recycling department in your city. If you do not have access to a take-back programme, see the FDA’s Safe Disposal of Medicines website at http://goo.gl/c4Rm4p for additional information.
As many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and are simple for young children to open, it is crucial to keep all medications out of sight and out of reach of children. Always lock safety caps and promptly stash medication up and away from young children where it is out of their sight and reach to prevent poisoning. http://www.upandaway.org
In case of emergency/overdose
Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Additionally, information can be found online at https://www.poisonhelp.org/help. Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.
What other information should I know?
Keep all of your appointments with your physician and the lab. Before, during, and after your therapy, your doctor will request specific lab tests to see how well your body is responding to adalimumab.
Do not share your medication with anybody else. Any queries you may have regarding medication refills should be directed to your pharmacist.
You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.
- Abrilada® (adalimumab-afzb)
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- Cyltezo® (adalimumab-adbm)
- Hadlima® (adalimumab-bwwd)
- Hulio® (adalimumab-fkjp)
- Humira® (adalimumab)
- Hyrimoz® (adalimumab-adaz)
- Yusimry® (adalimumab-aqvh)