Avsola 100mg Inj, 1 Vial
WARNING: This drug may raise the chance of infection, including severe infections. Sometimes severe infections have led to death. Most people who had these infections were taking other drugs to lower the immune system like methotrexate or steroid drugs. If you have any infection, are taking antibiotics now or in the recent past, or have had many infections, talk with your doctor.TB (tuberculosis) has been seen in patients started on this drug. These patients were exposed to TB in the past, but never got the infection. You will be tested to see if you have been exposed to TB before starting this drug.Lymphoma and other cancers have happened in people who take this drug or drugs like it. This has been deadly in some cases. Talk with the doctor.A rare type of cancer called hepatosplenic T-cell lymphoma (HSTCL) has happened with this drug and other drugs like it. These cases have been deadly. Almost all cases were in people who were using drugs like this one along with certain other drugs (azathioprine or mercaptopurine). Most of the time, this happened during treatment for Crohn's disease or ulcerative colitis. Also, most cases were in male teenagers or young males. Talk with the doctor. @ COMMON USES: It is used to treat Crohn's disease.It is used to treat some types of arthritis.It is used to treat plaque psoriasis.It is used to treat ankylosing spondylitis.It is used to treat ulcerative colitis.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Immunosuppressant
Pharmacologic Class
Tumor Necrosis Factor (TNF) Blocker; Monoclonal Antibody
Pregnancy Category
Category B
FDA Approved
Sep 2016
DEA Schedule
Not Controlled
Overview
What is this medicine?
Avsola is a medicine given by infusion into a vein to help reduce inflammation in conditions like Crohn's disease, ulcerative colitis, rheumatoid arthritis, and psoriasis. It works by blocking a natural protein in your body called TNF-alpha, which can cause inflammation.
How to Use This Medicine
To use this medication correctly, follow your doctor's instructions and carefully read all accompanying information. Take this medication exactly as directed, and adhere to all guidelines provided. This drug is administered as an intravenous infusion, which means it is given into a vein over a specified period of time.
If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the proper storage procedure.
If you miss a dose, contact your doctor immediately to receive guidance on the appropriate course of action.
If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the proper storage procedure.
If you miss a dose, contact your doctor immediately to receive guidance on the appropriate course of action.
Lifestyle & Tips
- Report any signs of infection (fever, chills, cough, flu-like symptoms) immediately to your doctor.
- Avoid live vaccines while on Avsola. Discuss any vaccinations with your doctor.
- Inform all healthcare providers that you are taking Avsola before any medical procedures or new medications.
- Limit exposure to people with infections.
- Maintain good hygiene to reduce infection risk.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Varies by indication. For Crohn's Disease/Ulcerative Colitis: 5 mg/kg IV infusion at 0, 2, and 6 weeks, then every 8 weeks. For Rheumatoid Arthritis/Psoriatic Arthritis/Ankylosing Spondylitis: 3 mg/kg IV infusion at 0, 2, and 6 weeks, then every 8 weeks (RA may be increased to 10 mg/kg or given every 4 weeks if needed). For Plaque Psoriasis: 5 mg/kg IV infusion at 0, 2, and 6 weeks, then every 8 weeks.
Dose Range:
3 - 10 mg
Condition-Specific Dosing:
Crohn's Disease:
5 mg/kg IV at 0, 2, 6 weeks, then every 8 weeks. Some patients may benefit from dose escalation to 10 mg/kg or dose interval reduction to every 4 weeks.
Ulcerative Colitis:
5 mg/kg IV at 0, 2, 6 weeks, then every 8 weeks. Some patients may benefit from dose escalation to 10 mg/kg or dose interval reduction to every 4 weeks.
Rheumatoid Arthritis:
3 mg/kg IV at 0, 2, 6 weeks, then every 8 weeks. May increase to 10 mg/kg or administer every 4 weeks if response is inadequate.
Psoriatic Arthritis:
5 mg/kg IV at 0, 2, 6 weeks, then every 8 weeks.
Ankylosing Spondylitis:
5 mg/kg IV at 0, 2, 6 weeks, then every 8 weeks.
Plaque Psoriasis:
5 mg/kg IV at 0, 2, 6 weeks, then every 8 weeks.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Crohn's Disease (6-17 years): 5 mg/kg IV at 0, 2, 6 weeks, then every 8 weeks. Ulcerative Colitis (6-17 years): 5 mg/kg IV at 0, 2, 6 weeks, then every 8 weeks.
Adolescent:
Crohn's Disease (6-17 years): 5 mg/kg IV at 0, 2, 6 weeks, then every 8 weeks. Ulcerative Colitis (6-17 years): 5 mg/kg IV at 0, 2, 6 weeks, then every 8 weeks.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Dialysis:
Not significantly cleared by dialysis; no specific recommendations for adjustment.
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Pharmacology
Mechanism of Action
Infliximab is a chimeric IgG1 monoclonal antibody that specifically binds to both soluble and transmembrane forms of tumor necrosis factor alpha (TNFα) with high affinity and specificity. It neutralizes the biological activity of TNFα by preventing its binding to its receptors, thereby reducing inflammation and immune responses. TNFα is a pro-inflammatory cytokine involved in systemic inflammation and various immune-mediated diseases.
Pharmacokinetics
Absorption:
Bioavailability:
100% (administered intravenously)
Tmax:
Achieved at the end of the intravenous infusion
FoodEffect:
Not applicable (IV administration)
Distribution:
Vd:
Approximately 3 L (central compartment)
ProteinBinding:
Not applicable in the conventional sense for monoclonal antibodies; binds specifically to TNFα.
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 8 to 9.5 days
Clearance:
Approximately 10 to 14 mL/hr/kg
ExcretionRoute:
Primarily via the reticuloendothelial system (catabolism of proteins)
Unchanged:
Not applicable (metabolized)
Pharmacodynamics
OnsetOfAction:
Varies by indication; typically within 2-14 weeks for clinical response.
PeakEffect:
Peak serum concentrations are achieved at the end of the infusion. Clinical peak effect varies.
DurationOfAction:
Approximately 8 weeks (based on dosing interval), but can vary based on patient response and immunogenicity.
Safety & Warnings
BLACK BOX WARNING
SERIOUS INFECTIONS: Patients treated with infliximab are at increased risk for developing serious infections that may lead to hospitalization or death. These infections include active tuberculosis (TB), invasive fungal infections (e.g., histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, pneumocystosis), and other bacterial, viral, and opportunistic infections. Evaluate patients for TB risk factors and test for latent infection prior to and during therapy. Initiate treatment for latent TB prior to infliximab. Monitor all patients for signs and symptoms of infection during and after treatment. MALIGNANCY: Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including infliximab. Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare, aggressive, and fatal lymphoma, have been reported in adolescents and young adults with Crohn's disease or ulcerative colitis treated with TNF blockers, including infliximab. The majority of reported cases occurred in patients treated with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker. Cases of acute and chronic leukemia have been reported. Melanoma and Merkel cell carcinoma have been reported in TNF blocker-treated patients.
Side Effects
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 or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin with or without fever
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Signs of infection, including:
+ Fever or chills
+ Severe sore throat, ear or sinus pain, or cough
+ Increased or discolored sputum
+ Painful urination or mouth sores
+ Wounds that do not heal
Signs of lupus, such as:
+ Rash on the cheeks or other body parts
+ Easy sunburning
+ Muscle or joint pain
+ Chest pain or shortness of breath
+ Swelling in the arms or legs
Unexplained bruising or bleeding
Pale skin
Skin lumps or growths
Abnormal vaginal bleeding
Pelvic pain or vaginal discharge
Fast or slow heartbeat
Red, scaly patches or pus-filled bumps
Fever, chills, itching, hives, chest pain or pressure, or shortness of breath after receiving the medication (note: other medications may be given to prevent these reactions)
If you experience any of the following, contact your doctor right away:
Swollen glands, night sweats, shortness of breath, or unexplained weight loss
Fever, rash, severe headache, sore throat, muscle or joint pain, swelling of the face or hands, or difficulty swallowing (these reactions can occur up to 12 days after receiving the medication)
Serious Cardiovascular and Neurological Side Effects
In some cases, this medication has been associated with serious cardiovascular and neurological side effects, including:
Abnormal heartbeats, heart attacks, high or low blood pressure, and strokes (which can be fatal)
Short-term vision loss (occurring during or within 2 hours after infusion)
Nervous system problems, such as burning, numbness, or tingling sensations, changes in vision, dizziness, seizures, or weakness in the arms or legs (which can be permanent)
If you experience any of the following, seek medical attention immediately:
Abnormal heartbeat, chest pain or pressure, or loss of vision
Signs of high or low blood pressure, such as severe headache, dizziness, or fainting
Weakness on one side of the body, difficulty speaking or thinking, changes in balance, confusion, drooping on one side of the face, or blurred vision
Other Serious Side Effects
This medication has also been associated with:
Liver problems (which can be fatal)
Heart failure (which can be fatal, especially in people with pre-existing heart disease)
If you experience any of the following, contact your doctor right away:
Signs of liver problems, such as dark urine, fatigue, decreased appetite, nausea, stomach pain, light-colored stools, vomiting, or yellow skin or eyes
Shortness of breath, significant weight gain, abnormal heartbeat, or swelling in the arms or legs (especially if you have pre-existing heart disease)
Common Side Effects
Most people do not experience serious side effects, but some may occur. If you notice any of the following, contact your doctor or seek medical attention if they bother you or do not go away:
Headache
Diarrhea, stomach pain, nausea, or vomiting
Fatigue or weakness
Flushing
Signs of a common cold
* Pain, redness, swelling, or reaction at the injection site
Reporting Side Effects
If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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 or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin with or without fever
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Signs of infection, including:
+ Fever or chills
+ Severe sore throat, ear or sinus pain, or cough
+ Increased or discolored sputum
+ Painful urination or mouth sores
+ Wounds that do not heal
Signs of lupus, such as:
+ Rash on the cheeks or other body parts
+ Easy sunburning
+ Muscle or joint pain
+ Chest pain or shortness of breath
+ Swelling in the arms or legs
Unexplained bruising or bleeding
Pale skin
Skin lumps or growths
Abnormal vaginal bleeding
Pelvic pain or vaginal discharge
Fast or slow heartbeat
Red, scaly patches or pus-filled bumps
Fever, chills, itching, hives, chest pain or pressure, or shortness of breath after receiving the medication (note: other medications may be given to prevent these reactions)
If you experience any of the following, contact your doctor right away:
Swollen glands, night sweats, shortness of breath, or unexplained weight loss
Fever, rash, severe headache, sore throat, muscle or joint pain, swelling of the face or hands, or difficulty swallowing (these reactions can occur up to 12 days after receiving the medication)
Serious Cardiovascular and Neurological Side Effects
In some cases, this medication has been associated with serious cardiovascular and neurological side effects, including:
Abnormal heartbeats, heart attacks, high or low blood pressure, and strokes (which can be fatal)
Short-term vision loss (occurring during or within 2 hours after infusion)
Nervous system problems, such as burning, numbness, or tingling sensations, changes in vision, dizziness, seizures, or weakness in the arms or legs (which can be permanent)
If you experience any of the following, seek medical attention immediately:
Abnormal heartbeat, chest pain or pressure, or loss of vision
Signs of high or low blood pressure, such as severe headache, dizziness, or fainting
Weakness on one side of the body, difficulty speaking or thinking, changes in balance, confusion, drooping on one side of the face, or blurred vision
Other Serious Side Effects
This medication has also been associated with:
Liver problems (which can be fatal)
Heart failure (which can be fatal, especially in people with pre-existing heart disease)
If you experience any of the following, contact your doctor right away:
Signs of liver problems, such as dark urine, fatigue, decreased appetite, nausea, stomach pain, light-colored stools, vomiting, or yellow skin or eyes
Shortness of breath, significant weight gain, abnormal heartbeat, or swelling in the arms or legs (especially if you have pre-existing heart disease)
Common Side Effects
Most people do not experience serious side effects, but some may occur. If you notice any of the following, contact your doctor or seek medical attention if they bother you or do not go away:
Headache
Diarrhea, stomach pain, nausea, or vomiting
Fatigue or weakness
Flushing
Signs of a common cold
* Pain, redness, swelling, or reaction at the injection site
Reporting Side Effects
If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Signs of serious infection: fever, chills, persistent cough, shortness of breath, flu-like symptoms, skin sores, burning urination.
- Allergic reactions during or after infusion: rash, hives, itching, difficulty breathing, chest tightness, swelling of face/lips/tongue/throat, dizziness.
- Signs of heart failure: new or worsening shortness of breath, swelling of ankles or feet, sudden weight gain.
- Neurological problems: numbness, tingling, weakness in arms or legs, vision changes, seizures.
- Liver problems: yellowing of skin or eyes (jaundice), dark urine, severe stomach pain, unusual tiredness.
- Blood problems: unusual bruising or bleeding, pale skin, persistent fever, sore throat.
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following conditions to ensure safe treatment:
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 allergic to mouse proteins, discuss this with your doctor.
If you have a history of heart failure, also known as a weak heart.
If you have been diagnosed with any of the following conditions: blood vessel inflammation, chronic obstructive pulmonary disease (COPD), multiple sclerosis, nerve problems, or seizures.
Additionally, tell your doctor about any medications you are currently taking, including:
Abatacept, anakinra, or tocilizumab
Any other medications similar to this one. If you are unsure, consult your doctor or pharmacist.
This list is not exhaustive, and it is crucial to disclose all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems to your doctor and pharmacist. They will help you determine if it is safe to take this medication with your existing treatments and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
It is essential to inform your doctor about the following conditions to ensure safe treatment:
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 allergic to mouse proteins, discuss this with your doctor.
If you have a history of heart failure, also known as a weak heart.
If you have been diagnosed with any of the following conditions: blood vessel inflammation, chronic obstructive pulmonary disease (COPD), multiple sclerosis, nerve problems, or seizures.
Additionally, tell your doctor about any medications you are currently taking, including:
Abatacept, anakinra, or tocilizumab
Any other medications similar to this one. If you are unsure, consult your doctor or pharmacist.
This list is not exhaustive, and it is crucial to disclose all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems to your doctor and pharmacist. They will help you determine if it is safe to take this medication with your existing treatments and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Your doctor will likely recommend regular blood tests and other laboratory evaluations to monitor your condition. Be aware that this medication may interfere with certain lab tests, so it is crucial to notify all your healthcare providers and laboratory personnel that you are taking this drug.
Using this medication can lead to low blood cell counts, which may increase the risk of bleeding problems, infections, or anemia. In severe cases, these complications can be life-threatening. If you have any concerns or questions, discuss them with your doctor.
You may be more susceptible to infections while taking this medication. To minimize this risk, practice good hygiene by washing your hands frequently, and avoid close contact with people who have infections, colds, or flu. Ensure you are up to date with all recommended vaccinations before starting treatment with this drug. However, consult your doctor before receiving any vaccines, as some may increase the risk of infection when used with this medication.
Additionally, avoid receiving weakened bacteria, such as BCG, for bladder cancer treatment while using this drug. Consult your doctor for guidance. Regular skin checks are also recommended, and you should promptly report any skin changes, such as new warts, skin sores, reddish bumps that bleed or do not heal, or changes in the color or size of moles, to your doctor.
If you have a history of hepatitis B or are a carrier of the virus, this medication can cause the virus to become active, leading to potentially severe and life-threatening liver problems. You will undergo hepatitis B testing before starting this medication and will need to monitor for signs of hepatitis while taking the drug and for several months after discontinuing it. Discuss any concerns with your doctor.
Older adults (60 years or older) should use this medication with caution, as they may be more prone to side effects. Similarly, children should use this medication with caution, as the risk of certain side effects may be higher in this population.
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor, as they will need to discuss the potential benefits and risks of this medication to you and your baby. If you used this medication during pregnancy, be sure to inform your baby's doctor, as they will need to discuss the safety and timing of certain vaccines with you.
Using this medication can lead to low blood cell counts, which may increase the risk of bleeding problems, infections, or anemia. In severe cases, these complications can be life-threatening. If you have any concerns or questions, discuss them with your doctor.
You may be more susceptible to infections while taking this medication. To minimize this risk, practice good hygiene by washing your hands frequently, and avoid close contact with people who have infections, colds, or flu. Ensure you are up to date with all recommended vaccinations before starting treatment with this drug. However, consult your doctor before receiving any vaccines, as some may increase the risk of infection when used with this medication.
Additionally, avoid receiving weakened bacteria, such as BCG, for bladder cancer treatment while using this drug. Consult your doctor for guidance. Regular skin checks are also recommended, and you should promptly report any skin changes, such as new warts, skin sores, reddish bumps that bleed or do not heal, or changes in the color or size of moles, to your doctor.
If you have a history of hepatitis B or are a carrier of the virus, this medication can cause the virus to become active, leading to potentially severe and life-threatening liver problems. You will undergo hepatitis B testing before starting this medication and will need to monitor for signs of hepatitis while taking the drug and for several months after discontinuing it. Discuss any concerns with your doctor.
Older adults (60 years or older) should use this medication with caution, as they may be more prone to side effects. Similarly, children should use this medication with caution, as the risk of certain side effects may be higher in this population.
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor, as they will need to discuss the potential benefits and risks of this medication to you and your baby. If you used this medication during pregnancy, be sure to inform your baby's doctor, as they will need to discuss the safety and timing of certain vaccines with you.
Overdose Information
Overdose Symptoms:
- No specific symptoms of overdose have been identified in clinical trials. Doses up to 20 mg/kg have been administered without dose-limiting toxicity.
What to Do:
In case of suspected overdose, supportive care and monitoring for adverse reactions are recommended. Call 1-800-222-1222 (Poison Control Center) for further guidance.
Drug Interactions
Contraindicated Interactions
- Live vaccines (e.g., BCG, measles, mumps, rubella, polio, rotavirus, yellow fever, varicella, zoster, typhoid)
- Anakinra (increased risk of serious infection and neutropenia)
- Abatacept (increased risk of serious infection)
Major Interactions
- Other TNF blockers (e.g., adalimumab, etanercept) - increased risk of serious infection and neutropenia
- Immunosuppressants (e.g., azathioprine, methotrexate, cyclosporine) - increased risk of serious infection (though often used concomitantly for efficacy, requires careful monitoring)
- Vaccines (live attenuated) - risk of infection from vaccine strain
Moderate Interactions
- Non-live vaccines (may have reduced immune response)
- Tocilizumab (increased risk of infection)
Monitoring
Baseline Monitoring
Tuberculosis (TB) screening (PPD or IGRA)
Rationale: To rule out latent or active TB infection, as TNF blockers can reactivate latent TB.
Timing: Prior to initiation of therapy
Hepatitis B Virus (HBV) screening (HBsAg, anti-HBc)
Rationale: To rule out active or chronic HBV infection, as TNF blockers can reactivate HBV.
Timing: Prior to initiation of therapy
Complete Blood Count (CBC) with differential
Rationale: To assess for baseline cytopenias and monitor for potential hematologic abnormalities.
Timing: Prior to initiation of therapy
Liver Function Tests (LFTs) - ALT, AST, bilirubin
Rationale: To assess for baseline hepatic impairment and monitor for drug-induced liver injury.
Timing: Prior to initiation of therapy
Cardiac function assessment (e.g., clinical evaluation for heart failure)
Rationale: Infliximab is contraindicated in moderate to severe heart failure.
Timing: Prior to initiation of therapy
Routine Monitoring
Signs and symptoms of infection
Frequency: Before each infusion and ongoing
Target: Absence of fever, chills, cough, dysuria, skin lesions, etc.
Action Threshold: Any new or worsening signs/symptoms of infection; hold infusion and investigate.
Infusion reactions (acute and delayed)
Frequency: During and immediately after infusion, and up to 14 days post-infusion
Target: Absence of rash, urticaria, dyspnea, hypotension, fever, chills, headache
Action Threshold: Any signs of infusion reaction; stop infusion, manage symptoms, consider pre-medication for future infusions.
Complete Blood Count (CBC) with differential
Frequency: Periodically, or as clinically indicated (e.g., if signs of infection or cytopenia)
Target: Within normal limits
Action Threshold: Significant decrease in cell counts (e.g., neutropenia, thrombocytopenia); investigate and consider holding therapy.
Liver Function Tests (LFTs)
Frequency: Periodically, or as clinically indicated (e.g., if signs of liver injury)
Target: Within normal limits
Action Threshold: Significant elevation of transaminases; investigate and consider holding therapy.
Signs and symptoms of heart failure
Frequency: Ongoing clinical assessment
Target: Absence of new or worsening dyspnea, edema, fatigue
Action Threshold: New onset or worsening heart failure symptoms; discontinue infliximab.
Signs and symptoms of neurological disorders (e.g., demyelinating disease)
Frequency: Ongoing clinical assessment
Target: Absence of new or worsening numbness, tingling, weakness, visual disturbances
Action Threshold: New onset or worsening neurological symptoms; discontinue infliximab.
Symptom Monitoring
- Fever
- Chills
- Sore throat
- Cough
- Shortness of breath
- Unusual bruising or bleeding
- Persistent fatigue
- Yellowing of skin or eyes (jaundice)
- Dark urine
- Abdominal pain
- Swelling in ankles/feet
- New or worsening rash
- Numbness or tingling
- Weakness in limbs
- Vision changes
- Headache
Special Patient Groups
Pregnancy
Infliximab crosses the placenta, particularly during the third trimester. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Live vaccines should not be administered to infants exposed to infliximab in utero for at least 6 months after birth.
Trimester-Specific Risks:
First Trimester:
Limited data, but generally considered low risk of structural abnormalities.
Second Trimester:
Increasing placental transfer as pregnancy progresses.
Third Trimester:
Highest placental transfer, leading to detectable levels in infant serum at birth. Potential for immunosuppression in the infant.
Lactation
Infliximab is present in human milk at low levels. The amount absorbed systemically by a breastfed infant is expected to be low due to its large molecular weight and susceptibility to proteolytic degradation in the infant's gastrointestinal tract. Generally considered compatible with breastfeeding, but monitor infant for signs of infection.
Infant Risk:
Low risk of adverse effects; monitor for signs of infection.
Pediatric Use
Approved for Crohn's disease and ulcerative colitis in children aged 6 years and older. Increased risk of malignancy (e.g., hepatosplenic T-cell lymphoma) has been reported in children and adolescents treated with TNF blockers, especially with concomitant azathioprine or 6-mercaptopurine.
Geriatric Use
Increased incidence of serious infections and malignancies in patients 65 years of age and older. Use with caution and monitor closely for adverse events.
Clinical Information
Clinical Pearls
- Avsola is a biosimilar to Remicade; it is not an interchangeable product unless designated by the FDA.
- Pre-medication (e.g., antihistamines, corticosteroids, acetaminophen) may be used to reduce the risk of infusion reactions, especially in patients with a history of such reactions.
- Patients should be screened for latent tuberculosis and hepatitis B before starting therapy and monitored for reactivation during and after treatment.
- Immunogenicity (development of antibodies to infliximab) can occur, potentially leading to infusion reactions or loss of response. Concomitant immunosuppressants (e.g., methotrexate, azathioprine) can reduce antibody formation.
- Patients with moderate to severe heart failure should not receive infliximab due to increased risk of worsening heart failure and mortality.
- Monitor for new or worsening neurological symptoms, as rare cases of demyelinating disorders have been reported.
Alternative Therapies
- Other TNF-alpha inhibitors (e.g., adalimumab, etanercept, golimumab, certolizumab pegol)
- Interleukin inhibitors (e.g., ustekinumab, secukinumab, ixekizumab)
- Integrin receptor antagonists (e.g., vedolizumab, natalizumab)
- Janus kinase (JAK) inhibitors (e.g., tofacitinib, upadacitinib)
- Selective co-stimulation modulators (e.g., abatacept)
- Conventional immunosuppressants (e.g., methotrexate, azathioprine, cyclosporine)
- Corticosteroids (e.g., prednisone)
- Aminosalicylates (for IBD, e.g., mesalamine)
Cost & Coverage
Average Cost:
Highly variable, typically several thousand USD per vial per 100mg vial
Insurance Coverage:
Specialty Tier (requires prior authorization, often subject to step therapy)
General Drug Facts
If your symptoms or health problems persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others, and do not take medication prescribed for someone else. Store all medications in a secure location, out of the reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly. Unless instructed to do so by a healthcare professional, do not flush medications down the toilet or pour them down the drain. If you are unsure about the proper disposal method, consult your pharmacist, who can also inform you about potential drug take-back programs in your area.
This medication is accompanied by a Medication Guide, which provides important information about its use. It is crucial to read this guide carefully and review it again each time your prescription is refilled. If you have any questions or concerns about this medication, discuss them with your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time it was taken, as this will aid in receiving appropriate treatment.
This medication is accompanied by a Medication Guide, which provides important information about its use. It is crucial to read this guide carefully and review it again each time your prescription is refilled. If you have any questions or concerns about this medication, discuss them with your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time it was taken, as this will aid in receiving appropriate treatment.