Humira Pen 40mg Crohn Str Kit-6pen

Adalimumab is a recombinant human IgG1 monoclonal antibody that specifically binds to human tumor necrosis factor (TNF) alpha and neutralizes its biological function by blocking its interaction with the p55 and p75 cell surface TNF receptors. TNF-alpha is a naturally occurring cytokine involved in normal inflammatory and immune responses. Elevated levels of TNF-alpha are found in the synovial fluid of patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis, and in the intestinal mucosa of patients with Crohn's disease and ulcerative colitis. Adalimumab also lyses surface TNF-expressing cells in vitro in the presence of complement.

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek medical attention:

Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Signs of infection: fever, chills, severe sore throat, ear or sinus pain, cough, increased or changed sputum production, painful urination, mouth sores, or a wound that won't heal.
Signs of a urinary tract infection (UTI): blood in the urine, burning or pain while urinating, frequent or urgent need to urinate, fever, lower abdominal pain, or pelvic pain.
Signs of lupus: rash on the cheeks or other body parts, easy sunburn, muscle or joint pain, chest pain or shortness of breath, or swelling in the arms or legs.
Signs of high blood pressure: severe headache or dizziness, fainting, or changes in vision.
A skin lump or growth, pale skin, or red, scaly patches or bumps filled with pus.
Swollen glands, night sweats, shortness of breath, or unexplained weight loss.
Nervous system problems: burning, numbness, or tingling sensations, changes in vision, dizziness, seizures, or weakness in the arms or legs.
Liver problems: dark urine, fatigue, decreased appetite, stomach upset or pain, light-colored stools, vomiting, or yellow skin or eyes.
Heart failure: shortness of breath, significant weight gain, irregular heartbeat, or new or worsening swelling in the arms or legs.

Pre-existing Heart Disease: If you have heart disease, inform your doctor. Monitor your condition closely and seek medical help if you experience any of the above symptoms.

Blood Cell Problems: If you experience extreme fatigue, weakness, fever, chills, shortness of breath, unexplained bruising or bleeding, or purple spots on the skin, contact your doctor immediately.

Other Side Effects

Most people taking this medication do not experience severe side effects. However, some may encounter mild or moderate side effects. If you experience any of the following, contact your doctor if they bother you or persist:

Headache
Common cold symptoms
Stomach pain
Upset stomach
Back pain
Pain, redness, swelling, or reaction at the injection site

Reporting Side Effects

This is not an exhaustive list of potential side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you are currently taking abatacept or anakinra, as these medications may interact with this drug.
* If you are using another medication similar to this one. If you are unsure, consult your doctor or pharmacist for clarification.

Please note that this is not an exhaustive list of all potential interactions. To ensure your safety, it is crucial to discuss all of your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. Additionally, inform them about any existing health problems.

Remember, before starting, stopping, or changing the dose of any medication, including this one, you must consult with your doctor to confirm that it is safe to do so in conjunction with your other medications and health conditions.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

While using this drug, you may be more susceptible to infections. To minimize this risk, practice good hygiene by washing your hands frequently and avoid close contact with individuals who have infections, colds, or flu.

If you have a history of hepatitis B or are a carrier of the virus, it is crucial to discuss this with your doctor. Medications like this one can cause the hepatitis B virus to become active, leading to severe and potentially life-threatening liver problems. Your doctor will likely recommend hepatitis B testing, and it is vital to follow their instructions.

Before starting treatment with this drug, ensure you are up to date with all recommended vaccinations. However, consult your doctor before receiving any vaccines, as some may not be effective or may increase the risk of infection when used in conjunction with this medication.

Do not receive a weakened bacteria vaccine, such as BCG for bladder cancer, while taking this drug. Instead, consult your doctor for guidance.

Regular blood tests and other laboratory evaluations are necessary while using this medication. Adhere to the schedule recommended by your doctor.

High cholesterol is a potential side effect of this drug. If you have concerns or questions, discuss them with your doctor.

If you have a latex allergy, inform your doctor, as some products may contain latex.

In the event of sunburn or other skin problems, consult your doctor. Additionally, schedule regular skin checks and promptly report any new or changing skin lesions, such as warts, sores, or moles, to your doctor.

If you are 65 years or older, use this medication with caution, as you may be more prone to side effects.

Pregnant or breastfeeding women, or those planning to become pregnant, should discuss the benefits and risks of this medication with their doctor. If you used this drug during pregnancy, inform your baby's doctor to discuss the safety and timing of certain vaccines.

• Live vaccines (e.g., MMR, varicella, rotavirus, yellow fever, BCG) during adalimumab therapy and for at least 3 months after discontinuation.
• Anakinra (Kineret) - increased risk of serious infection and neutropenia.
• Abatacept (Orencia) - increased risk of serious infection.

• Other TNF blockers (e.g., infliximab, etanercept) - increased risk of serious infection.
• Immunosuppressants (e.g., azathioprine, 6-mercaptopurine, methotrexate) - increased risk of myelosuppression and serious infection when used concomitantly, though often used together in practice with careful monitoring.
• Natalizumab (Tysabri) - increased risk of progressive multifocal leukoencephalopathy (PML).

• Corticosteroids - may increase risk of infection, but often used concomitantly during induction.
• Warfarin - potential for altered INR, monitor closely.

• Signs of serious infection (persistent fever, chills, cough, shortness of breath, fatigue, skin lesions, painful urination)
• Signs of allergic reaction (rash, hives, swelling, difficulty breathing)
• Signs of new or worsening heart failure (shortness of breath, swelling of ankles/feet, sudden weight gain)
• Signs of lupus-like syndrome (joint pain, rash on cheeks/nose, fever, chest pain)
• Signs of demyelinating disease (numbness, tingling, weakness, vision changes)
• Signs of blood dyscrasias (persistent fever, bruising, bleeding, pallor)
• Signs of malignancy (unexplained weight loss, persistent fever, night sweats, swollen lymph nodes, new skin lesions)

Adalimumab is an IgG1 antibody and is known to cross the placenta, especially during the third trimester. Limited data from observational studies and registries suggest no increased risk of major birth defects or miscarriage. However, due to potential for immunosuppression in the infant, live vaccines should be avoided in infants exposed to adalimumab in utero for at least 6 months after the last maternal dose during pregnancy.

Adalimumab is present in human milk at very low concentrations. Systemic absorption by a breastfed infant is unlikely due to the large molecular weight of the antibody, which is expected to be largely destroyed in the infant's gastrointestinal tract. Therefore, breastfeeding is generally considered compatible with adalimumab use, but caution is advised.

Approved for various pediatric indications including Crohn's disease (≥6 years), ulcerative colitis (≥5 years), juvenile idiopathic arthritis (≥2 years), psoriatic arthritis (≥2 years), plaque psoriasis (≥4 years), hidradenitis suppurativa (≥12 years), and uveitis (≥2 years). Increased risk of malignancy (lymphoma) has been reported in children and adolescents treated with TNF blockers.

No overall differences in safety or effectiveness were observed between elderly and younger patients, but a greater sensitivity of some older individuals cannot be ruled out. Higher incidence of serious infections in patients >65 years of age treated with TNF blockers.

• Adalimumab is a biologic agent that requires careful screening for infections (especially TB and HBV) before initiation.
• Patients should be educated on the importance of reporting any signs of infection promptly.
• The long half-life means that effects (both therapeutic and adverse) can persist for several weeks after discontinuation.
• Biosimilars are available, offering potentially lower cost alternatives, but patients should be aware of potential differences in formulation or administration devices.
• Immunogenicity (antibody formation against adalimumab) can occur, potentially leading to loss of response over time. Therapeutic drug monitoring (TDM) may be considered in some cases of secondary loss of response.

• Other TNF-alpha inhibitors (e.g., infliximab, golimumab, certolizumab pegol)
• Integrin receptor antagonists (e.g., vedolizumab, natalizumab)
• Interleukin inhibitors (e.g., ustekinumab)
• Janus kinase (JAK) inhibitors (e.g., tofacitinib, upadacitinib)
• Corticosteroids (for induction)
• Immunomodulators (e.g., azathioprine, 6-mercaptopurine, methotrexate)
• 5-aminosalicylates (e.g., mesalamine)
• Surgery (for refractory cases or complications)

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. Please read this guide carefully and review it again whenever you refill your prescription. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the quantity, and the time it occurred.