Taltz 80mg/ml Autoinjector 3s
It is used to treat plaque psoriasis. It is used to treat some types of arthritis.It is used to treat ankylosing spondylitis.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Immunosuppressant, Selective
Pharmacologic Class
Interleukin-17A (IL-17A) Antagonist
Pregnancy Category
Not available
FDA Approved
Mar 2016
DEA Schedule
Not Controlled
Overview
What is this medicine?
Taltz is a medicine given by injection under the skin. It works by blocking a protein in your body called IL-17A, which is involved in causing inflammation. By blocking this protein, Taltz helps to reduce the redness, scaling, and itching of psoriasis, and the pain and swelling of psoriatic arthritis, ankylosing spondylitis, and non-radiographic axial spondyloarthritis.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is administered via injection into the fatty tissue of the skin, typically on the top of the thigh, belly area, or upper arm. If you will be self-administering the injection, your doctor or nurse will instruct you on the proper technique.
Before using this medication, remove it from the refrigerator and allow it to sit at room temperature for 30 minutes. Do not expose the medication to heat, microwave it, submerge it in hot water, or leave it in direct sunlight. Wash your hands before and after handling the medication.
When administering the injection, rotate the injection site with each dose to avoid irritation. Do not shake the medication or inject it into skin that is irritated, bruised, red, infected, hard, or scarred. Additionally, avoid injecting into skin affected by psoriasis or within 1 inch of the belly button. Check the solution for cloudiness, leakage, or particles before use. The medication should be colorless to faint yellow; if the color changes, do not use it.
After administering the dose, discard any remaining medication and dispose of the needle in a designated sharps container. Do not reuse needles or other equipment. When the container is full, follow local regulations for disposal. If you have difficulty hearing or seeing, consider having someone else administer the injection. If you have any questions, consult your doctor or pharmacist.
Storage and Disposal
Store this medication in the refrigerator at all times, except when removing it to administer a dose. Do not freeze the medication, and do not use it if it has been frozen. Keep the medication in its original container, protected from light. If necessary, you can store the medication at room temperature in its original carton for up to 5 days. Record the date you remove the medication from the refrigerator, and if it is not used within 5 days, discard it.
Missed Dose
If you miss a dose, take it as soon as you remember and resume your regular schedule. If the missed dose is close to the time for your next dose, skip the missed dose and continue with your regular schedule. Do not take two doses at the same time or take extra doses. If you are unsure about what to do in case of a missed dose, consult your doctor.
To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is administered via injection into the fatty tissue of the skin, typically on the top of the thigh, belly area, or upper arm. If you will be self-administering the injection, your doctor or nurse will instruct you on the proper technique.
Before using this medication, remove it from the refrigerator and allow it to sit at room temperature for 30 minutes. Do not expose the medication to heat, microwave it, submerge it in hot water, or leave it in direct sunlight. Wash your hands before and after handling the medication.
When administering the injection, rotate the injection site with each dose to avoid irritation. Do not shake the medication or inject it into skin that is irritated, bruised, red, infected, hard, or scarred. Additionally, avoid injecting into skin affected by psoriasis or within 1 inch of the belly button. Check the solution for cloudiness, leakage, or particles before use. The medication should be colorless to faint yellow; if the color changes, do not use it.
After administering the dose, discard any remaining medication and dispose of the needle in a designated sharps container. Do not reuse needles or other equipment. When the container is full, follow local regulations for disposal. If you have difficulty hearing or seeing, consider having someone else administer the injection. If you have any questions, consult your doctor or pharmacist.
Storage and Disposal
Store this medication in the refrigerator at all times, except when removing it to administer a dose. Do not freeze the medication, and do not use it if it has been frozen. Keep the medication in its original container, protected from light. If necessary, you can store the medication at room temperature in its original carton for up to 5 days. Record the date you remove the medication from the refrigerator, and if it is not used within 5 days, discard it.
Missed Dose
If you miss a dose, take it as soon as you remember and resume your regular schedule. If the missed dose is close to the time for your next dose, skip the missed dose and continue with your regular schedule. Do not take two doses at the same time or take extra doses. If you are unsure about what to do in case of a missed dose, consult your doctor.
Lifestyle & Tips
- Maintain good hygiene to reduce the risk of infections.
- Report any signs of infection (e.g., fever, chills, persistent cough, skin sores) to your doctor immediately.
- Avoid live vaccines while on Taltz. Discuss any planned vaccinations with your doctor.
- Inform all healthcare providers that you are taking Taltz before any medical procedures or new medications.
- Store Taltz in the refrigerator (2°C to 8°C or 36°F to 46°F) in the original carton to protect from light. Do not freeze. Do not shake.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Initial 160 mg (two 80 mg injections) at Week 0, then 80 mg every 2 weeks for Weeks 2, 4, 6, 8, 10, and 12, followed by 80 mg every 4 weeks thereafter.
Dose Range:
80 - 160 mg
Condition-Specific Dosing:
Plaque Psoriasis:
Initial 160 mg (two 80 mg injections) at Week 0, then 80 mg every 2 weeks for Weeks 2, 4, 6, 8, 10, and 12, followed by 80 mg every 4 weeks thereafter.
Psoriatic Arthritis:
Initial 160 mg (two 80 mg injections) at Week 0, then 80 mg every 4 weeks thereafter. For PsA patients with co-existent moderate to severe plaque psoriasis, use the plaque psoriasis dosing regimen.
Ankylosing Spondylitis:
Initial 160 mg (two 80 mg injections) at Week 0, then 80 mg every 4 weeks thereafter.
Non-radiographic Axial Spondyloarthritis:
Initial 160 mg (two 80 mg injections) at Week 0, then 80 mg every 4 weeks thereafter.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
For moderate-to-severe plaque psoriasis in patients 6 years and older weighing at least 50 kg: Initial 160 mg (two 80 mg injections) at Week 0, then 80 mg every 4 weeks thereafter. For patients weighing less than 50 kg: 40 mg at Week 0, then 40 mg every 4 weeks thereafter.
Adolescent:
For moderate-to-severe plaque psoriasis in patients 6 years and older weighing at least 50 kg: Initial 160 mg (two 80 mg injections) at Week 0, then 80 mg every 4 weeks thereafter. For patients weighing less than 50 kg: 40 mg at Week 0, then 40 mg every 4 weeks thereafter.
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment recommended.
Moderate:
No dose adjustment recommended.
Severe:
No dose adjustment recommended.
Dialysis:
No specific recommendations; not expected to be dialyzable due to large molecular weight.
Hepatic Impairment:
Mild:
No dose adjustment recommended.
Moderate:
No dose adjustment recommended.
Severe:
No dose adjustment recommended.
Pharmacology
Mechanism of Action
Ixekizumab is a humanized IgG4 monoclonal antibody that selectively binds to the interleukin-17A (IL-17A) cytokine and inhibits its interaction with the IL-17 receptor. IL-17A is a naturally occurring cytokine involved in normal inflammatory and immune responses. Ixekizumab inhibits the release of pro-inflammatory cytokines and chemokines, thereby reducing the inflammatory cascade associated with conditions like plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and non-radiographic axial spondyloarthritis.
Pharmacokinetics
Absorption:
Bioavailability:
54-90%
Tmax:
4-7 days
FoodEffect:
Not applicable (subcutaneous injection)
Distribution:
Vd:
7.11 L (central compartment)
ProteinBinding:
Not applicable (monoclonal antibody)
CnssPenetration:
Limited
Elimination:
HalfLife:
13 days
Clearance:
0.07 L/day
ExcretionRoute:
Primarily via catabolism; not renally or hepatically excreted in an unchanged form.
Unchanged:
Not applicable (catabolized)
Pharmacodynamics
OnsetOfAction:
Within 2-4 weeks (clinical response)
PeakEffect:
Typically by Week 12-16 for maximal response
DurationOfAction:
Maintained with regular dosing (every 2 or 4 weeks)
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
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 help right away:
Signs of an allergic reaction, such as:
+ 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
+ Swelling of the mouth, face, lips, tongue, or throat
Some patients with severe allergic reactions may require hospitalization.
Signs of infection, including:
+ Fever
+ Chills
+ Severe sore throat
+ Ear or sinus pain
+ Cough
+ Increased or changed sputum production
+ Painful urination
+ Mouth sores
+ Wounds that won't heal
Warm, red, or painful skin or sores on the body
Redness or white patches in the mouth or throat
Eye redness
Stomach pain or diarrhea
Bloody diarrhea
Weight loss
Severe dizziness or fainting
Severe skin problems resembling eczema, which can occur within days to months after the first dose. These may require hospital treatment. If you experience any of the following, contact your doctor immediately:
+ Rash
+ Itching
+ Dry or leathery skin
+ Small bumps or patches
+ Redness
+ Blisters
+ Peeling
+ Other skin irritation
Other Possible Side Effects
Like all medications, this drug can cause side effects. However, many people may not experience any side effects or only minor ones. If you're concerned about any of the following side effects or if they persist, contact your doctor:
Irritation at the injection site
Upset stomach
Common cold symptoms
This is not an exhaustive list of possible side effects. If you have questions or concerns, 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.
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 help right away:
Signs of an allergic reaction, such as:
+ 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
+ Swelling of the mouth, face, lips, tongue, or throat
Some patients with severe allergic reactions may require hospitalization.
Signs of infection, including:
+ Fever
+ Chills
+ Severe sore throat
+ Ear or sinus pain
+ Cough
+ Increased or changed sputum production
+ Painful urination
+ Mouth sores
+ Wounds that won't heal
Warm, red, or painful skin or sores on the body
Redness or white patches in the mouth or throat
Eye redness
Stomach pain or diarrhea
Bloody diarrhea
Weight loss
Severe dizziness or fainting
Severe skin problems resembling eczema, which can occur within days to months after the first dose. These may require hospital treatment. If you experience any of the following, contact your doctor immediately:
+ Rash
+ Itching
+ Dry or leathery skin
+ Small bumps or patches
+ Redness
+ Blisters
+ Peeling
+ Other skin irritation
Other Possible Side Effects
Like all medications, this drug can cause side effects. However, many people may not experience any side effects or only minor ones. If you're concerned about any of the following side effects or if they persist, contact your doctor:
Irritation at the injection site
Upset stomach
Common cold symptoms
This is not an exhaustive list of possible side effects. If you have questions or concerns, 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.
Seek Immediate Medical Attention If You Experience:
- Signs of serious infection: fever, chills, body aches, persistent cough, shortness of breath, warm/red/painful skin, open sores on your body, diarrhea, stomach pain, weight loss.
- Signs of allergic reaction: rash, hives, swelling of your face, lips, tongue, or throat, difficulty breathing or swallowing.
- New or worsening symptoms of inflammatory bowel disease: persistent abdominal pain, diarrhea, bloody stools, weight loss.
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:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you have been diagnosed with tuberculosis (TB).
This list is not exhaustive, and it is crucial to discuss all your medications, health conditions, and concerns with your doctor. Please provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your health problems, including any medical conditions or diseases
To ensure your safety, do not start, stop, or change the dose of any medication without first consulting your doctor. It is vital to verify that it is safe to take this medication with all your other medications and health conditions.
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 allergic reaction you experienced, including any symptoms that occurred.
If you have been diagnosed with tuberculosis (TB).
This list is not exhaustive, and it is crucial to discuss all your medications, health conditions, and concerns with your doctor. Please provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your health problems, including any medical conditions or diseases
To ensure your safety, do not start, stop, or change the dose of any medication without first consulting your doctor. It is vital to verify that it is safe to take this medication with all your other medications and health conditions.
Precautions & Cautions
Important Information for Patients Taking This Medication
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Before Starting Treatment
A tuberculosis (TB) test is required before initiating this medication.
You may be at a higher risk of developing infections, which can be severe and may require hospitalization. To minimize this risk:
+ Wash your hands frequently.
+ Avoid close contact with people who have infections, colds, or flu.
Special Considerations
If you have inflammatory bowel disease, such as ulcerative colitis or Crohn's disease, discuss your condition with your doctor. This medication may cause new or worsening inflammatory bowel disease, which can be severe.
Ensure you are up to date with all recommended vaccinations before starting treatment with this medication.
Consult your doctor before receiving any vaccines, as some vaccines may not be effective or may increase the risk of infection when taken with this medication.
Pregnancy and Breastfeeding
If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the benefits and risks of this medication with your doctor.
Pediatric Patients
The dosage of this medication is based on your child's weight.
Some doses may need to be administered by a healthcare provider.
* If you have questions or concerns about your child's dosage, consult with their doctor.
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Before Starting Treatment
A tuberculosis (TB) test is required before initiating this medication.
You may be at a higher risk of developing infections, which can be severe and may require hospitalization. To minimize this risk:
+ Wash your hands frequently.
+ Avoid close contact with people who have infections, colds, or flu.
Special Considerations
If you have inflammatory bowel disease, such as ulcerative colitis or Crohn's disease, discuss your condition with your doctor. This medication may cause new or worsening inflammatory bowel disease, which can be severe.
Ensure you are up to date with all recommended vaccinations before starting treatment with this medication.
Consult your doctor before receiving any vaccines, as some vaccines may not be effective or may increase the risk of infection when taken with this medication.
Pregnancy and Breastfeeding
If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the benefits and risks of this medication with your doctor.
Pediatric Patients
The dosage of this medication is based on your child's weight.
Some doses may need to be administered by a healthcare provider.
* If you have questions or concerns about your child's dosage, consult with their doctor.
Overdose Information
Overdose Symptoms:
- No specific symptoms of overdose have been reported in clinical trials. Doses up to 180 mg have been administered without dose-limiting toxicity.
What to Do:
In case of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions and appropriate symptomatic treatment be instituted immediately. Call 1-800-222-1222 (Poison Control Center) for further guidance.
Drug Interactions
Contraindicated Interactions
- Live vaccines (e.g., BCG, measles, mumps, rubella, varicella, yellow fever, oral polio, rotavirus, nasal influenza)
Major Interactions
- Immunosuppressants (e.g., cyclosporine, methotrexate): Potential for increased risk of infection or additive immunosuppression. Use with caution.
- Other biologics targeting IL-17 or TNF-alpha: Increased risk of serious infection. Concomitant use is not recommended.
Moderate Interactions
- Non-live vaccines: May result in a diminished immune response to vaccination. Administer all age-appropriate immunizations prior to initiating Taltz.
Confidence Interactions
Monitoring
Baseline Monitoring
Tuberculosis (TB) screening (latent and active)
Rationale: Risk of reactivation of latent TB or new active TB infection. Taltz should not be given to patients with active TB. Treat latent TB prior to initiation.
Timing: Prior to initiation of Taltz
Hepatitis B Virus (HBV) screening
Rationale: Risk of HBV reactivation in chronic carriers. Consider antiviral therapy if indicated.
Timing: Prior to initiation of Taltz
Inflammatory Bowel Disease (IBD) history
Rationale: New or worsening Crohn's disease or ulcerative colitis has been reported. Assess patient history.
Timing: Prior to initiation of Taltz
Routine Monitoring
Signs and symptoms of infection (e.g., fever, chills, malaise, cough, skin lesions)
Frequency: Regularly during treatment and after discontinuation
Target: Absence of infection
Action Threshold: Prompt medical evaluation and potential interruption of Taltz if serious infection develops.
Symptoms of inflammatory bowel disease (e.g., abdominal pain, diarrhea, weight loss)
Frequency: Regularly during treatment
Target: Absence of new or worsening IBD symptoms
Action Threshold: Discontinue Taltz if new or worsening IBD symptoms occur.
Injection site reactions
Frequency: With each injection
Target: Minimal to no reaction
Action Threshold: Severe reactions may warrant discontinuation.
Symptom Monitoring
- Signs of infection (fever, chills, persistent cough, shortness of breath, skin warmth/redness/pain, oral sores)
- Symptoms of inflammatory bowel disease (persistent abdominal pain, diarrhea, bloody stools, weight loss)
- Signs of allergic reaction (rash, hives, swelling of face/lips/tongue/throat, difficulty breathing)
- New or worsening joint pain/swelling (for PsA patients)
- Skin changes (for psoriasis patients)
Special Patient Groups
Pregnancy
There are no adequate and well-controlled studies of Taltz in pregnant women. Monoclonal antibodies, including ixekizumab, are known to cross the placental barrier. A pregnancy exposure registry is available for women exposed to Taltz during pregnancy (1-800-284-1695). Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Limited data. Risk of exposure is generally lower in the first trimester for IgG antibodies.
Second Trimester:
Increased placental transfer of IgG antibodies occurs during the second and third trimesters.
Third Trimester:
Highest placental transfer of IgG antibodies. Potential for immunosuppression in the infant, though clinical significance is unknown. Consider avoiding live vaccines in infants exposed to Taltz in utero for at least 6 months after birth.
Lactation
Ixekizumab is an IgG4 antibody and is expected to be present in human milk. Published data suggest that the amount of IgG in breast milk is low and absorption by the infant is minimal. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Taltz and any potential adverse effects on the breastfed infant from Taltz or from the underlying maternal condition. Consider the infant's potential for oral absorption and the potential for adverse effects.
Infant Risk:
Low risk. Due to the large molecular weight of ixekizumab, it is unlikely to be absorbed systemically by the infant. However, monitor for signs of infection.
Pediatric Use
Taltz is approved for the treatment of moderate-to-severe plaque psoriasis in pediatric patients 6 years of age and older weighing at least 50 kg (160 mg initial dose, then 80 mg q4w) or weighing less than 50 kg (40 mg initial dose, then 40 mg q4w). Safety and effectiveness in pediatric patients for other indications (PsA, AS, nr-axSpA) have not been established. The safety profile in pediatric patients with plaque psoriasis was consistent with the safety profile in adults.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly patients (≥65 years of age) and younger adult patients. No dose adjustment is necessary in elderly patients.
Clinical Information
Clinical Pearls
- Taltz is a biologic agent and should be administered by a healthcare professional or by the patient/caregiver after proper training.
- Patients should be screened for tuberculosis (TB) and Hepatitis B Virus (HBV) prior to initiating Taltz.
- Advise patients to report any signs or symptoms of infection promptly.
- New or worsening inflammatory bowel disease (Crohn's disease or ulcerative colitis) has been reported with IL-17 inhibitors. Monitor patients for symptoms.
- Live vaccines are contraindicated during Taltz treatment. Ensure all age-appropriate immunizations are up-to-date before starting therapy.
- Injection site reactions (erythema, pain, pruritus, bruising) are common but usually mild to moderate and transient.
Alternative Therapies
- Other IL-17 inhibitors (e.g., secukinumab, brodalumab)
- TNF-alpha inhibitors (e.g., adalimumab, etanercept, infliximab, certolizumab pegol, golimumab)
- IL-23 inhibitors (e.g., guselkumab, risankizumab, tildrakizumab)
- Oral systemic agents (e.g., methotrexate, cyclosporine, apremilast)
- PDE4 inhibitors (e.g., apremilast)
- JAK inhibitors (e.g., tofacitinib, upadacitinib)
- Phototherapy (e.g., UVB, PUVA)
- Topical therapies (e.g., corticosteroids, vitamin D analogs, retinoids, calcineurin inhibitors)
Cost & Coverage
Average Cost:
Highly variable, typically >$5,000 - $10,000 per 2 autoinjectors (160mg dose) or 3 autoinjectors (80mg dose)
Insurance Coverage:
Specialty Tier (requires prior authorization, step therapy, and/or quantity limits)
General Drug Facts
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, which provides crucial information for patients. Please read this guide carefully and review it again whenever you receive a refill of this medication. 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 amount, and the time it occurred.