Taltz 80mg/ml Autoinjector 2s
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, Monoclonal Antibody
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 that helps reduce inflammation in your body. It works by blocking a specific protein called IL-17A, which plays a role in conditions like psoriasis and psoriatic arthritis. By blocking this protein, Taltz can help clear skin plaques, reduce joint pain and swelling, and improve overall symptoms.
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 in the top of the thigh, belly area, or upper arm. If you will be self-administering the injection, your doctor or nurse will provide guidance on the proper technique.
Before using this medication, remove it from the refrigerator and allow it to reach room temperature for 30 minutes. Do not expose the medication to heat, microwave, hot water, or direct sunlight. Wash your hands before and after handling the medication. Rotate the injection site with each use to avoid irritation.
Important Administration Guidelines
Do not shake the medication.
Avoid injecting into skin that is irritated, bruised, red, infected, hard, or scarred.
Do not inject into skin affected by psoriasis.
Avoid injecting 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 solution has changed color, do not use it.
Disposal and Storage
Dispose of any remaining medication after use.
Throw away needles and other sharp objects in a designated disposal box. Do not reuse needles or other items. Follow local regulations for disposing of the full box.
If you have difficulty hearing or seeing, consider having someone else administer the injection. Consult your doctor or pharmacist if you have any questions.
Storage Instructions
Store the medication in the refrigerator at all times, unless otherwise specified.
Do not freeze the medication.
Keep the medication in its original container to protect it 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. If not used within 5 days, discard the medication.
Missed Dose Instructions
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 of your next scheduled dose, skip the missed dose and continue with your regular schedule.
Do not take two doses at the same time or 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 in the top of the thigh, belly area, or upper arm. If you will be self-administering the injection, your doctor or nurse will provide guidance on the proper technique.
Before using this medication, remove it from the refrigerator and allow it to reach room temperature for 30 minutes. Do not expose the medication to heat, microwave, hot water, or direct sunlight. Wash your hands before and after handling the medication. Rotate the injection site with each use to avoid irritation.
Important Administration Guidelines
Do not shake the medication.
Avoid injecting into skin that is irritated, bruised, red, infected, hard, or scarred.
Do not inject into skin affected by psoriasis.
Avoid injecting 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 solution has changed color, do not use it.
Disposal and Storage
Dispose of any remaining medication after use.
Throw away needles and other sharp objects in a designated disposal box. Do not reuse needles or other items. Follow local regulations for disposing of the full box.
If you have difficulty hearing or seeing, consider having someone else administer the injection. Consult your doctor or pharmacist if you have any questions.
Storage Instructions
Store the medication in the refrigerator at all times, unless otherwise specified.
Do not freeze the medication.
Keep the medication in its original container to protect it 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. If not used within 5 days, discard the medication.
Missed Dose Instructions
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 of your next scheduled dose, skip the missed dose and continue with your regular schedule.
Do not take two doses at the same time or extra doses.
If you are unsure about what to do in case of a missed dose, consult your doctor.
Lifestyle & Tips
- Follow your doctor's instructions for administration and dosing.
- Keep all appointments for follow-up and monitoring.
- Report any signs of infection (fever, chills, persistent cough, skin sores) to your doctor immediately.
- Avoid live vaccines while on Taltz. Discuss any planned vaccinations with your doctor.
- Store Taltz in the refrigerator, protected from light. Do not freeze.
- Allow the autoinjector to reach room temperature for 30 minutes before injecting. Do not warm it in any other way.
- Do not shake the autoinjector.
- Rotate injection sites (thighs, abdomen, upper arms) with each dose.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Varies by indication. For Plaque Psoriasis: 160 mg (two 80 mg injections) subcutaneously at Week 0, followed by 80 mg at Weeks 2, 4, 6, 8, 10, and 12, then 80 mg every 4 weeks. For Psoriatic Arthritis: 160 mg (two 80 mg injections) subcutaneously at Week 0, followed by 80 mg every 4 weeks. For Ankylosing Spondylitis/Non-radiographic Axial Spondyloarthritis: 160 mg (two 80 mg injections) subcutaneously at Week 0, followed by 80 mg every 4 weeks.
Dose Range:
80 - 160 mg
Condition-Specific Dosing:
Plaque Psoriasis:
160 mg (two 80 mg injections) at Week 0, then 80 mg every 2 weeks through Week 12, then 80 mg every 4 weeks.
Psoriatic Arthritis:
160 mg (two 80 mg injections) at Week 0, then 80 mg every 4 weeks. For PsA patients with concomitant moderate to severe plaque psoriasis, the dosing regimen for plaque psoriasis should be used.
Ankylosing Spondylitis:
160 mg (two 80 mg injections) at Week 0, then 80 mg every 4 weeks.
Non-radiographic Axial Spondyloarthritis:
160 mg (two 80 mg injections) at Week 0, then 80 mg every 4 weeks.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
For pediatric patients 6 years and older weighing at least 50 kg with moderate-to-severe plaque psoriasis: 160 mg (two 80 mg injections) at Week 0, then 80 mg every 4 weeks. For pediatric patients 6 years and older weighing less than 50 kg with moderate-to-severe plaque psoriasis: 80 mg at Week 0, then 40 mg every 4 weeks.
Adolescent:
Same as child dosing for plaque psoriasis. For Psoriatic Arthritis in pediatric patients 2 years and older: Dosing is weight-based. For patients weighing <25 kg: 40 mg every 4 weeks. For patients weighing ≥25 kg to <50 kg: 80 mg every 4 weeks. For patients weighing ≥50 kg: 160 mg at Week 0, then 80 mg every 4 weeks.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Dialysis:
No specific studies conducted; unlikely to be removed by dialysis due to large molecular weight.
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No specific studies conducted; unlikely to be significantly affected as monoclonal antibodies are primarily catabolized by reticuloendothelial system.
Pharmacology
Mechanism of Action
Ixekizumab is a humanized IgG4 monoclonal antibody that selectively binds with high affinity to the interleukin 17A (IL-17A) cytokine and inhibits its interaction with the IL-17 receptor. IL-17A is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. Ixekizumab inhibits the release of pro-inflammatory cytokines and chemokines.
Pharmacokinetics
Absorption:
Bioavailability:
54% to 90% (subcutaneous)
Tmax:
4 to 7 days
FoodEffect:
Not applicable (subcutaneous administration)
Distribution:
Vd:
7.11 L (population mean)
ProteinBinding:
Not applicable (monoclonal antibody)
CnssPenetration:
Limited
Elimination:
HalfLife:
13 days (mean)
Clearance:
0.39 L/day (population mean)
ExcretionRoute:
Primarily via catabolism; not renally or hepatically cleared in the traditional sense.
Unchanged:
Not applicable (protein degradation)
Pharmacodynamics
OnsetOfAction:
Clinical improvement seen as early as 2 weeks for psoriasis.
PeakEffect:
Varies by endpoint; maximal response typically by 12-16 weeks.
DurationOfAction:
Maintained with continued dosing every 2 or 4 weeks.
Confidence:
High
Safety & Warnings
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 immediately or seek emergency medical attention:
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 right away:
+ 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. Many people may not experience any side effects or only minor ones. If you're bothered by 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 immediately or seek emergency medical attention:
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 right away:
+ 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. Many people may not experience any side effects or only minor ones. If you're bothered by 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, painful urination.
- Symptoms of inflammatory bowel disease: new or worsening abdominal pain, persistent diarrhea, weight loss, bloody stools.
- Allergic reactions: rash, hives, swelling of face/lips/tongue/throat, difficulty breathing.
- Injection site reactions that are severe or do not go away (e.g., large area of redness, swelling, pain).
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 is not an exhaustive list of potential interactions. Therefore, it is crucial to discuss all of your medications, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins, with your doctor and pharmacist. Additionally, share any existing health problems to ensure safe use of this medication.
To guarantee your safety, do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor. It is vital to verify that it is safe to take this medication in conjunction with all of 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 is not an exhaustive list of potential interactions. Therefore, it is crucial to discuss all of your medications, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins, with your doctor and pharmacist. Additionally, share any existing health problems to ensure safe use of this medication.
To guarantee your safety, do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor. It is vital to verify that it is safe to take this medication in conjunction with all of your other medications and health conditions.
Precautions & Cautions
Important Information for Patients Taking This Medication
It is crucial that you inform all of 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 are at a higher risk of developing infections, which can be severe and may require hospitalization. To minimize this risk, practice good hygiene by washing your hands frequently and avoid close contact with individuals who have infections, colds, or flu.
Special Considerations
If you have a history of inflammatory bowel disease, such as ulcerative colitis or Crohn's disease, consult with your doctor. This medication may exacerbate or trigger new cases of inflammatory bowel disease, which can be severe.
Ensure that you are up to date with all recommended vaccinations before starting treatment with this medication.
Consult with your doctor before receiving any vaccines, as some vaccines may increase the risk of infection or reduce their effectiveness when taken with this medication.
Pregnancy and Breastfeeding
If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the potential benefits and risks of this medication with your doctor.
Pediatric Patients
* The dosage of this medication is based on your child's weight, and some doses may need to be administered by a healthcare provider. If you have questions or concerns, consult with your child's doctor.
It is crucial that you inform all of 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 are at a higher risk of developing infections, which can be severe and may require hospitalization. To minimize this risk, practice good hygiene by washing your hands frequently and avoid close contact with individuals who have infections, colds, or flu.
Special Considerations
If you have a history of inflammatory bowel disease, such as ulcerative colitis or Crohn's disease, consult with your doctor. This medication may exacerbate or trigger new cases of inflammatory bowel disease, which can be severe.
Ensure that you are up to date with all recommended vaccinations before starting treatment with this medication.
Consult with your doctor before receiving any vaccines, as some vaccines may increase the risk of infection or reduce their effectiveness when taken with this medication.
Pregnancy and Breastfeeding
If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the potential benefits and risks of this medication with your doctor.
Pediatric Patients
* The dosage of this medication is based on your child's weight, and some doses may need to be administered by a healthcare provider. If you have questions or concerns, consult with your child's doctor.
Overdose Information
Overdose Symptoms:
- No specific symptoms of overdose have been reported in clinical trials. Doses up to 180 mg subcutaneously 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, rotavirus, live attenuated influenza vaccine) - concurrent administration is contraindicated due to potential for infection.
Moderate Interactions
- Non-live vaccines: May reduce the immune response to vaccination. Administer non-live vaccines according to immunization guidelines prior to initiating ixekizumab or during treatment if clinically appropriate.
Monitoring
Baseline Monitoring
Tuberculosis (TB) screening
Rationale: To rule out latent or active TB infection before initiating treatment, as ixekizumab may increase the risk of TB reactivation.
Timing: Prior to initiation of therapy
Hepatitis B and C screening
Rationale: Although not explicitly required by all guidelines, some clinicians screen for chronic viral hepatitis due to immunosuppressive nature, especially if risk factors are present.
Timing: Prior to initiation of therapy (optional, based on risk factors)
Routine Monitoring
Signs and symptoms of infection
Frequency: Regularly throughout treatment
Target: Absence of fever, chills, malaise, new or worsening cough, dysuria, skin lesions, etc.
Action Threshold: Prompt evaluation and treatment if infection suspected; consider interrupting ixekizumab until infection resolves.
Signs and symptoms of inflammatory bowel disease (IBD)
Frequency: Regularly throughout treatment
Target: Absence of new or worsening abdominal pain, diarrhea, weight loss, bloody stools.
Action Threshold: Prompt evaluation if IBD symptoms occur; consider discontinuing ixekizumab if IBD develops or worsens.
Injection site reactions
Frequency: Regularly, especially after initial injections
Target: Minimal redness, swelling, or pain at injection site.
Action Threshold: Severe reactions may warrant discontinuation or re-evaluation of administration technique.
Symptom Monitoring
- Signs of serious infection (e.g., persistent fever, chills, fatigue, shortness of breath, persistent cough, skin warmth/redness/pain, diarrhea, abdominal pain)
- Symptoms of inflammatory bowel disease (e.g., new or worsening abdominal pain, diarrhea, weight loss, bloody stools)
- Symptoms of hypersensitivity reactions (e.g., rash, urticaria, dyspnea, angioedema)
- Injection site reactions (e.g., erythema, pain, induration, pruritus, bruising)
Special Patient Groups
Pregnancy
There are no adequate and well-controlled studies of Taltz in pregnant women. Monoclonal antibodies are known to cross the placental barrier, especially during the third trimester. 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, but generally, IgG antibodies cross the placenta minimally during the first trimester.
Second Trimester:
Increasing placental transfer of IgG antibodies.
Third Trimester:
Highest placental transfer of IgG antibodies, potentially leading to fetal exposure and immunosuppression in the neonate. Consider delaying live vaccinations in infants exposed to ixekizumab in utero for at least 6 months after birth.
Lactation
It is not known whether ixekizumab is excreted in human milk or absorbed systemically after ingestion. Human IgG is known to be excreted in breast milk. 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.
Infant Risk:
Low risk, as large protein molecules like ixekizumab are unlikely to be absorbed intact by the infant's gastrointestinal tract. However, potential for immunosuppression in the infant cannot be entirely ruled out.
Pediatric Use
Approved for moderate-to-severe plaque psoriasis in patients 6 years and older and for psoriatic arthritis in patients 2 years and older. Dosing is weight-based for pediatric patients. Safety and effectiveness in pediatric patients younger than 6 years for plaque psoriasis and younger than 2 years for psoriatic arthritis have not been established.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly patients (≥65 years) and younger adult patients. No dose adjustment is necessary in elderly patients.
Clinical Information
Clinical Pearls
- Taltz is a biologic agent, meaning it targets specific parts of the immune system. This makes it effective but also carries a risk of infection.
- Patients should be screened for tuberculosis (TB) before starting Taltz and monitored for signs of infection throughout treatment.
- Live vaccines should not be given concurrently with Taltz. Patients should complete all necessary vaccinations before starting therapy.
- Patients should be advised to report any new or worsening symptoms of inflammatory bowel disease (IBD), as IL-17 inhibitors have been associated with new onset or exacerbation of IBD.
- Proper injection technique and site rotation are crucial to minimize injection site reactions.
Alternative Therapies
- Other IL-17 inhibitors (e.g., secukinumab, brodalumab)
- TNF-alpha inhibitors (e.g., adalimumab, etanercept, infliximab, certolizumab, golimumab)
- IL-12/23 inhibitors (e.g., ustekinumab, guselkumab, risankizumab, tildrakizumab)
- PDE4 inhibitors (e.g., apremilast)
- Oral systemic agents (e.g., methotrexate, cyclosporine, acitretin)
- Phototherapy (e.g., UVB, PUVA)
- Topical therapies (for psoriasis)
Cost & Coverage
Average Cost:
Typically several thousand dollars per month/dose per 80mg/ml autoinjector
Insurance Coverage:
Specialty Tier (requires prior authorization, step therapy, and/or quantity limits for most commercial and Medicare plans)
General Drug Facts
If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure your safety and the effectiveness of your treatment, never share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, which is a valuable resource that provides important information about your treatment. Please read this guide carefully and review it again whenever you receive a refill of your medication. If you have any questions or concerns about your medication, do not hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, it is crucial to seek immediate medical attention. Call your local poison control center or visit the emergency room right away. When seeking help, be prepared to provide detailed information about the overdose, including the name of the medication taken, the amount consumed, and the time it occurred. This information will help healthcare professionals provide you with the most appropriate care and treatment.
This medication is accompanied by a Medication Guide, which is a valuable resource that provides important information about your treatment. Please read this guide carefully and review it again whenever you receive a refill of your medication. If you have any questions or concerns about your medication, do not hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, it is crucial to seek immediate medical attention. Call your local poison control center or visit the emergency room right away. When seeking help, be prepared to provide detailed information about the overdose, including the name of the medication taken, the amount consumed, and the time it occurred. This information will help healthcare professionals provide you with the most appropriate care and treatment.