Avsola (infliximab-axxq): Side Effects, Dosage & Warnings

Generic drug: infliximab-axxq

Brand name: Avsola

What is Avsola (infliximab-axxq), and how does it work?

Avsola (infliximab-axxq) is a prescription medicine that is approved for patients with:

Rheumatoid Arthritis — adults with moderately to severely active rheumatoid arthritis, along with the medicine methotrexate.
Crohn's Disease — children 6 years and older and adults with Crohn's disease who have not responded well to other medicines.
Ankylosing Spondylitis.
Psoriatic Arthritis.
Plaque Psoriasis — adult patients with plaque psoriasis that is chronic (does not go away), severe, extensive, and/or disabling.
Ulcerative Colitis — children 6 years and older and adults with moderately to severely active ulcerative colitis who have not responded well to other medicines.

Avsola blocks the action of a protein in your body called tumor necrosis factor-alpha (TNF-alpha). TNF-alpha ismade by your body's immune system. People with certain diseases have too much TNF-alpha that can cause theimmune system to attack normal healthy parts of the body. Avsola can block the damage caused by too much TNF-alpha.

What are the side effects of Avsola?

WARNING

SERIOUS INFECTIONS AND MALIGNANCY

Serious Infections

Patients treated with infliximab products are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.

Avsola should be discontinued if a patient develops a serious infection or sepsis.

Reported infections include:

Active tuberculosis, including reactivation of latent tuberculosis. Patients with tuberculosis have frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent tuberculosis before Avsola use and during therapy. Treatment for latent infection should be initiated prior to Avsola use.
Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Empiric anti-fungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness.
Bacterial, viral and other infections due to opportunistic pathogens, including Legionella and Listeria.

The risks and benefits of treatment with Avsola should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection.

Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with Avsola, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.

Malignancy

Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF-blockers, including infliximab products.

Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF-blockers including infliximab products. These cases have had a very aggressive disease course and have been fatal. Almost all patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF-blocker at or prior to diagnosis. The majority of reported cases have occurred in patients with Crohn’s disease or ulcerative colitis and most were in adolescent and young adult males.

Avsola can cause serious side effects, including:

Serious Infections

Some patients, especially those 65 years and older have had serious infections while receiving infliximab products, such as Avsola. These serious infections include TB and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some patients die from these infections. If you get an infection while receiving treatment with Avsola your doctor will treat your infection and may need to stop your Avsola treatment.
Tell your doctor right away if you have any of the following signs of an infection while receiving or after receiving Avsola:
- a fever
- have flu-like symptoms
- feel very tired
- warm, red, or painful skin
- have a cough
Your doctor will examine you for TB and perform a test to see if you have TB. If your doctor feels that you are atrisk for TB, you may be treated with medicine for TB before you begin treatment with Avsola and during treatment with Avsola.
Even if your TB test is negative, your doctor should carefully monitor you for TB infections while you are receiving Avsola. Patients who had a negative TB skin test before receiving infliximab products have developed active TB.
If you are a chronic carrier of the hepatitis B virus, the virus can become active while you are being treated with Avsola. In some cases, patients have died as a result of hepatitis B virus being reactivated. Your doctor should do a blood test for hepatitis B virus before you start treatment with Avsola and occasionally while you are being treated. Tell your doctor if you have any of the following symptoms:
- feel unwell
- tiredness (fatigue)
- poor appetite
- fever, skin rash, or joint pain

Heart Failure

If you have a heart problem called congestive heart failure, your doctor should check you closely while you are receiving Avsola. Your congestive heart failure may get worse while you are receiving Avsola. Be sure to tell your doctor of any new or worse symptoms including:

shortness of breath
sudden weight gain
swelling of ankles or feet

Treatment with Avsola may need to be stopped if you get new or worse congestive heart failure.

Other Heart Problems

Some patients have experienced a heart attack (some of which led to death), low blood flow to the heart, or abnormal heart rhythm within 24 hours of beginning their infusion of infliximab products. Symptoms may include

chest discomfort or pain,
arm pain,
stomach pain,
shortness of breath,
anxiety,
lightheadedness,
dizziness,
fainting,
sweating,
nausea,
vomiting,
fluttering or pounding in your chest, and/or
a fast or a slow heartbeat.

Tell your doctor right away if you have any of these symptoms.

Liver Injury

Some patients receiving infliximab products have developed serious liver problems. Tell your doctor if you have:

jaundice (skin and eyes turning yellow)
dark brown-colored urine
pain on the right side of your stomach area (right-sided abdominal pain)
fever
extreme tiredness (severe fatigue)

Blood Problems

In some patients receiving infliximab products, the body may not make enough of the blood cells that help fight infections or help stop bleeding. Tell your doctor if you:

have a fever that does not go away
look very pale
bruise or bleed very easily

Nervous System Disorders

Some patients receiving infliximab products have developed problems with their nervous system. Tell your doctor if you have:

changes in your vision
numbness or tingling in any part of your body
weakness in your arms or legs
seizures

Some patients have experienced a stroke within approximately 24 hours of their infusion with infliximab products. Tell your doctor right away if you have symptoms of a stroke which may include: numbness or weakness of the face, arm or leg, especially on one side of the body; sudden confusion, trouble speaking or understanding; sudden trouble seeing in one or both eyes, sudden trouble walking, dizziness, loss of balance or coordination or a sudden, severe headache.

Allergic Reactions

Some patients have had allergic reactions to infliximab products. Some of these reactions were severe. These reactions can happen while you are getting your Avsola treatment or shortly afterward. Your doctor may need to stop or pause your treatment with Avsola and may give you medicines to treat the allergic reaction. Signs of an allergic reaction can include:

hives (red, raised, itchy patches of skin)
high or low blood pressure
difficulty breathing
fever
chest pain
chills

Some patients treated with infliximab products have had delayed allergic reactions. The delayed reactions occurred 3 to 12 days after receiving treatment with infliximab products. Tell your doctor right away if you have any of these signs of delayed allergic reaction to Avsola:

fever
muscle or joint pain
rash
swelling of the face and hands
headache
difficulty swallowing
sore throat

Lupus-like Syndrome

Some patients have developed symptoms that are like the symptoms of Lupus. If you develop any of the following symptoms, your doctor may decide to stop your treatment with Avsola.

chest discomfort or pain that does not go away
joint pain
shortness of breath
rash on the cheeks or arms that gets worse in the sun

Psoriasis

Some people receiving infliximab products had new psoriasis or worsening of psoriasis they already had. Tell your doctor if you develop red scaly patches or raised bumps on the skin that are filled with pus. Your doctor may decide to stop your treatment with Avsola.

The most common side effects of infliximab products include:

respiratory infections, such as sinus
coughing
infections and sore throat
stomach pain
headache

Infusion reactions can happen up to 2 hours after your infusion of Avsola.

Symptoms of infusion reactions may include:

fever
shortness of breath
chills
rash
chest pain
itching
low blood pressure or high blood pressure

Children with Crohn's disease showed some differences in side effects compared with adults with Crohn's disease. The side effects that happened more in children were:

anemia (low red blood cells),
leukopenia (low white blood cells),
flushing (redness or blushing),
viral infections,
neutropenia (low neutrophils, the white blood cells that fight infection),
bone fracture,
bacterial infection and
allergic reactions of the breathing tract.

Among patients who received infliximab for ulcerative colitis in clinical studies, more children had infections as compared with adults.

Tell your doctor about any side effect that bothers you or does not go away. These are not all of the side effects with Avsola.

Ask your doctor or pharmacist for more information. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the dosage for Avsola?

Crohn’s Disease

The recommended dose of Avsola is 5 mg/kg given as an
intravenous induction regimen at 0, 2 and 6 weeks followed by a maintenance
regimen of 5 mg/kg every 8 weeks thereafter for the treatment of adults with
moderately to severely active Crohn’s disease or fistulizing Crohn’s disease.
For adult patients who respond and then lose their response, consideration may
be given to treatment with 10 mg/kg.
Patients who do not respond by Week 14 are
unlikely to respond with continued dosing and consideration should be given to
discontinue Avsola in these patients.

Pediatric Crohn’s Disease

The recommended dose of Avsola for pediatric patients 6
years and older with moderately to severely active Crohn’s disease is 5 mg/kg
given as an intravenous induction regimen at 0, 2 and 6 weeks followed by a
maintenance regimen of 5 mg/kg every 8 weeks.

Ulcerative Colitis

The recommended dose of Avsola is 5 mg/kg given as an
intravenous induction regimen at 0, 2 and 6 weeks followed by a maintenance
regimen of 5 mg/kg every 8 weeks thereafter for the treatment of adult patients
with moderately to severely active ulcerative colitis.

Pediatric Ulcerative Colitis

The recommended dose of Avsola for pediatric patients 6
years and older with moderately to severely active ulcerative colitis is 5
mg/kg given as an intravenous induction regimen at 0, 2 and 6 weeks followed by
a maintenance regimen of 5 mg/kg every 8 weeks.

Rheumatoid Arthritis

The recommended dose of Avsola is 3 mg/kg given as an intravenous induction
regimen at 0, 2 and 6 weeks followed by a maintenance regimen of 3 mg/kg every 8
weeks thereafter for the treatment of moderately to severely active rheumatoid
arthritis. Avsola should be given in combination with methotrexate.
For patients
who have an incomplete response, consideration may be given to adjusting the
dose up to 10 mg/kg or treating as often as every 4 weeks bearing in mind that
risk of serious infections is increased at higher doses.

Ankylosing Spondylitis

The recommended dose of Avsola is 5 mg/kg given as an
intravenous induction regimen at 0, 2 and 6 weeks followed by a maintenance
regimen of 5 mg/kg every 6 weeks thereafter for the treatment of active
ankylosing spondylitis.

Psoriatic Arthritis

The recommended dose of Avsola is 5 mg/kg given as an
intravenous induction regimen at 0, 2 and 6 weeks followed by a maintenance
regimen of 5 mg/kg every 8 weeks thereafter for the treatment of psoriatic
arthritis. Avsola can be used with or without methotrexate.

Plaque Psoriasis

The recommended dose of Avsola is 5 mg/kg given as an
intravenous induction regimen at 0, 2 and 6 weeks followed by a maintenance
regimen of 5 mg/kg every 8 weeks thereafter for the treatment of chronic severe
(i.e., extensive and/or disabling) plaque psoriasis.

Monitoring To Assess Safety

Prior to initiating Avsola and periodically during therapy, patients should
be evaluated for active tuberculosis and tested for latent infection.

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What drugs interact with Avsola?

Use With Anakinra Or Abatacept

An increased risk of serious infections was seen in clinical studies of
other TNFa-blocking agents used in combination with anakinra or abatacept,
with no added clinical benefit.
Because of the nature of the adverse reactions seen with these
combinations with TNF-blocker therapy, similar toxicities may also result
from the combination of anakinra or abatacept with other TNFa-blocking
agents. Therefore, the combination of Avsola and anakinra or abatacept is
not recommended.

Use With Tocilizumab

The use of tocilizumab in combination with biological
DMARDs such as TNF antagonists, including Avsola, should be avoided because of
the possibility of increased immunosuppression and increased risk of infection.

Use With Other Biological Therapeutics

The combination of Avsola with other biological therapeutics used to
treat the same conditions as Avsola is not recommended.

Methotrexate (MTX) And Other Concomitant Medications

Specific drug interaction studies, including interactions
with MTX, have not been conducted. The majority of patients in rheumatoid
arthritis or Crohn’s disease clinical studies received one or more concomitant
medications.
In rheumatoid arthritis, concomitant medications besides MTX were
non-steroidal anti-inflammatory agents (NSAIDs), folic acid, corticosteroids
and/or narcotics.
Concomitant Crohn’s disease medications were antibiotics,
antivirals, corticosteroids, 6-MP/AZA and aminosalicylates.
In psoriatic arthritis
clinical trials, concomitant medications included MTX in approximately half of
the patients as well as NSAIDs, folic acid and corticosteroids. Concomitant MTX
use may decrease the incidence of anti-drug antibody production and increase
infliximab product concentrations.

Immunosuppressants

Patients with Crohn’s disease who received immunosuppressants tended to
experience fewer infusion reactions compared to patients on no
immunosuppressants.
Serum
infliximab concentrations appeared to be unaffected by baseline use of
medications for the treatment of Crohn’s disease including corticosteroids,
antibiotics (metronidazole or ciprofloxacin) and aminosalicylates.

Cytochrome P450 Substrates

The formation of CYP450 enzymes may be suppressed by
increased levels of cytokines (e.g., TNFα, IL-1, IL-6, IL-10, IFN) during
chronic inflammation.
Therefore, it is expected that for a molecule that
antagonizes cytokine activity, such as infliximab products, the formation of
CYP450 enzymes could be normalized.
Upon initiation or discontinuation of
Avsola in patients being treated with CYP450 substrates with a narrow
therapeutic index, monitoring of the effect (e.g., warfarin) or drug
concentration (e.g., cyclosporine or theophylline) is recommended and the
individual dose of the drug product may be adjusted as needed.

Live Vaccines/Therapeutic Infectious Agents

It is recommended that live vaccines not be given concurrently with
Avsola. It is also recommended that live vaccines not be given to infants
after in utero exposure to infliximab products for at least 6 months
following birth.
It is recommended that therapeutic infectious agents not be given
concurrently with Avsola.

QUESTION

Ulcerative colitis affects the colon. The colon is also referred to as the…
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Is Avsola safe to use while pregnant or breastfeeding?

Available data from published literature on the use of infliximab products during pregnancy have not reported a clear association with infliximab products and adverse pregnancy outcomes.
Infliximab products cross the placenta and infants exposed in utero should not be administered live vaccines for at least 6 months after birth.
In a development study conducted in mice using an analogous antibody, no evidence of maternal toxicity, embryotoxicity or teratogenicity was observed.
Available information is insufficient to inform the amount of infliximab products present in human milk, and the effects on the breastfed infant.
There are no data on the effects of infliximab products on milk production.
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for an infliximab product and any potential adverse effects on the breastfed infant from infliximab products or from the underlying maternal condition.