Taltz 80mg/ml Autoinjector
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
Pharmacologic Class
Interleukin-17A (IL-17A) Inhibitor
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 is involved in causing the symptoms of conditions like psoriasis and psoriatic arthritis. It is given as an injection under the skin.
How to Use This Medicine
Proper Administration of This Medication
To ensure safe and effective use, follow your doctor's instructions and read all accompanying information carefully. This medication is administered via subcutaneous injection into the fatty tissue of 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 use, remove the medication from the refrigerator and allow it to reach room temperature for 30 minutes. Avoid exposing the medication to heat, microwaves, hot water, or direct sunlight. Wash your hands before and after handling the medication. Rotate the injection site with each dose to minimize the risk of 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 appears discolored, do not use it.
Dispose of any remaining medication after administration.
* Use a needle/sharp disposal box to discard used needles and do not reuse them. Follow local regulations for disposing of the box when it is full.
If you have difficulty hearing or seeing, consider having someone assist you with administering the injection. If you have any questions or concerns, consult your doctor or pharmacist.
Storage and Disposal
Store the medication in a refrigerator at a temperature between 2°C and 8°C (36°F and 46°F). Do not freeze. Keep the medication in its original container, protected from light. If necessary, you can store the medication at room temperature (up to 25°C or 77°F) for up to 5 days. Record the date you remove the medication from the refrigerator. If the medication is not used within 5 days of removal from the refrigerator, discard it.
Missed Dose Instructions
If you miss a dose, take it as soon as you remember and resume your regular dosing 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 take extra doses. If you are unsure about what to do in the event of a missed dose, consult your doctor.
To ensure safe and effective use, follow your doctor's instructions and read all accompanying information carefully. This medication is administered via subcutaneous injection into the fatty tissue of 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 use, remove the medication from the refrigerator and allow it to reach room temperature for 30 minutes. Avoid exposing the medication to heat, microwaves, hot water, or direct sunlight. Wash your hands before and after handling the medication. Rotate the injection site with each dose to minimize the risk of 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 appears discolored, do not use it.
Dispose of any remaining medication after administration.
* Use a needle/sharp disposal box to discard used needles and do not reuse them. Follow local regulations for disposing of the box when it is full.
If you have difficulty hearing or seeing, consider having someone assist you with administering the injection. If you have any questions or concerns, consult your doctor or pharmacist.
Storage and Disposal
Store the medication in a refrigerator at a temperature between 2°C and 8°C (36°F and 46°F). Do not freeze. Keep the medication in its original container, protected from light. If necessary, you can store the medication at room temperature (up to 25°C or 77°F) for up to 5 days. Record the date you remove the medication from the refrigerator. If the medication is not used within 5 days of removal from the refrigerator, discard it.
Missed Dose Instructions
If you miss a dose, take it as soon as you remember and resume your regular dosing 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 take extra doses. If you are unsure about what to do in the event 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) to your doctor immediately.
- Discuss all vaccinations with your doctor before starting Taltz; avoid live vaccines while on treatment.
- Inform your healthcare provider if you have a history of inflammatory bowel disease (Crohn's disease or ulcerative colitis) or if you develop new or worsening symptoms.
- Store Taltz in the refrigerator (2°C to 8°C / 36°F to 46°F) in its original carton to protect from light. Do not freeze. Do not shake.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Plaque Psoriasis: 160 mg (two 80 mg injections) at Week 0, then 80 mg at Weeks 2, 4, 6, 8, 10, and 12, then 80 mg every 4 weeks thereafter. Psoriatic Arthritis, Ankylosing Spondylitis, Non-radiographic axial SpA: 160 mg (two 80 mg injections) at Week 0, then 80 mg every 4 weeks thereafter.
Dose Range:
80 - 160 mg
Condition-Specific Dosing:
Plaque Psoriasis:
Initial 160 mg, then 80 mg every 2 weeks for 12 weeks, then 80 mg every 4 weeks.
Psoriatic Arthritis:
Initial 160 mg, then 80 mg every 4 weeks. For PsA patients with coexistent moderate to severe plaque psoriasis, use the plaque psoriasis dosing regimen.
Ankylosing Spondylitis:
Initial 160 mg, then 80 mg every 4 weeks.
Non-radiographic axial SpA:
Initial 160 mg, then 80 mg every 4 weeks.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Plaque Psoriasis (≥ 6 years of age and ≥ 50 kg): 160 mg (two 80 mg injections) at Week 0, then 80 mg every 4 weeks. Plaque Psoriasis (≥ 6 years of age and < 50 kg): 80 mg at Week 0, then 40 mg every 4 weeks (Note: 40 mg dose requires specific formulation or administration instructions not directly from an 80mg/ml autoinjector).
Adolescent:
Plaque Psoriasis (≥ 6 years of age and ≥ 50 kg): 160 mg (two 80 mg injections) at Week 0, then 80 mg every 4 weeks. Plaque Psoriasis (≥ 6 years of age and < 50 kg): 80 mg at Week 0, then 40 mg every 4 weeks (Note: 40 mg dose requires specific formulation or administration instructions not directly from an 80mg/ml autoinjector).
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 removed by dialysis 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 with high affinity to the interleukin 17A (IL-17A) cytokine, inhibiting 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 processes implicated in psoriasis, psoriatic arthritis, and axial spondyloarthritis.
Pharmacokinetics
Absorption:
Bioavailability:
54% to 90%
Tmax:
4 to 7 days
FoodEffect:
Not applicable (subcutaneous administration)
Distribution:
Vd:
Approximately 7.11 L
ProteinBinding:
Not extensively studied for monoclonal antibodies; generally low specific binding to plasma proteins.
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 13 days
Clearance:
Approximately 0.58 L/day
ExcretionRoute:
Catabolic degradation; not renally or hepatically excreted as intact drug.
Unchanged:
Not applicable (metabolized)
Pharmacodynamics
OnsetOfAction:
Clinical improvement observed as early as 2-4 weeks.
PeakEffect:
Peak clinical response typically seen by 12-16 weeks.
DurationOfAction:
Maintained with every 4-week dosing.
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 discolored sputum
+ 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 experience no side effects or only mild ones. If you're bothered by any of the following side effects or if they persist, contact your doctor or seek medical help:
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 about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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 discolored sputum
+ 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 experience no side effects or only mild ones. If you're bothered by any of the following side effects or if they persist, contact your doctor or seek medical help:
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 about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Signs of serious infection: fever, chills, body aches, persistent cough, shortness of breath, painful urination, severe diarrhea, skin warmth/redness/pain.
- Signs of allergic reaction: rash, hives, swelling of face/lips/tongue/throat, difficulty breathing or swallowing.
- Signs of new or worsening inflammatory bowel disease: persistent abdominal pain, diarrhea (especially bloody), 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 symptoms you experienced as a result of the allergy.
If you have been diagnosed with tuberculosis (TB).
This list is not exhaustive, and it is crucial to discuss all 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 start, stop, or modify the dosage of any medication without first consulting your doctor. It is vital to verify that this medication can be taken safely 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 symptoms you experienced as a result of the allergy.
If you have been diagnosed with tuberculosis (TB).
This list is not exhaustive, and it is crucial to discuss all 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 start, stop, or modify the dosage of any medication without first consulting your doctor. It is vital to verify that this medication can be taken safely 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.
Due to the increased risk of infection, it is crucial to practice good hygiene by washing your hands frequently and avoiding close contact with individuals who have infections, colds, or flu.
Special Precautions
If you have a history of inflammatory bowel disease, such as ulcerative colitis or Crohn's disease, consult with your doctor, as this medication may exacerbate these conditions, potentially leading to severe complications.
Ensure 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 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 potential benefits and risks of this medication with your doctor to make an informed decision.
Pediatric Patients
The dosage of this medication is based on the child's weight, and some doses may need to be administered by a healthcare provider.
If you have questions or concerns about your child's treatment, 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.
Due to the increased risk of infection, it is crucial to practice good hygiene by washing your hands frequently and avoiding close contact with individuals who have infections, colds, or flu.
Special Precautions
If you have a history of inflammatory bowel disease, such as ulcerative colitis or Crohn's disease, consult with your doctor, as this medication may exacerbate these conditions, potentially leading to severe complications.
Ensure 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 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 potential benefits and risks of this medication with your doctor to make an informed decision.
Pediatric Patients
The dosage of this medication is based on the child's weight, and some doses may need to be administered by a healthcare provider.
If you have questions or concerns about your child's treatment, consult with their doctor.
Overdose Information
Overdose Symptoms:
- No specific symptoms of overdose have been identified in clinical trials. Doses up to 180 mg have been administered without dose-limiting toxicity.
What to Do:
In case of suspected overdose, contact a poison control center (e.g., 1-800-222-1222) or seek immediate medical attention. Management should be supportive and directed toward the patient's symptoms.
Drug Interactions
Major Interactions
- Live vaccines (e.g., MMR, varicella, rotavirus, yellow fever, live attenuated influenza vaccine): Increased risk of infection. Avoid concurrent administration.
- Immunosuppressants (e.g., cyclosporine, methotrexate, corticosteroids): Increased risk of serious infections when used concomitantly, though specific studies are limited. Use with caution.
Monitoring
Baseline Monitoring
Tuberculosis (TB) screening
Rationale: To rule out latent or active TB infection before initiating treatment, as IL-17A inhibition may increase the risk of TB reactivation.
Timing: Prior to initiation of therapy.
Hepatitis B Virus (HBV) screening
Rationale: To assess for active or latent HBV infection, as immunosuppression may lead to HBV reactivation.
Timing: Prior to initiation of therapy.
Vaccination status review
Rationale: Ensure patients are up-to-date on all age-appropriate immunizations prior to initiating therapy. Avoid live vaccines.
Timing: Prior to initiation of therapy.
Routine Monitoring
Signs and symptoms of infection
Frequency: Regularly throughout therapy and after discontinuation.
Target: Absence of fever, chills, malaise, new or worsening cough, dysuria, skin lesions, etc.
Action Threshold: Prompt evaluation and treatment for any suspected serious infection. Consider temporary or permanent discontinuation of Taltz.
Signs and symptoms of inflammatory bowel disease (IBD)
Frequency: Regularly throughout therapy.
Target: Absence of new or worsening abdominal pain, diarrhea, rectal bleeding, weight loss.
Action Threshold: Prompt evaluation for new onset or exacerbation of IBD. Discontinue Taltz if IBD develops or worsens significantly.
Hypersensitivity reactions
Frequency: Monitor during and after injection.
Target: Absence of rash, urticaria, dyspnea, angioedema, anaphylaxis.
Action Threshold: Discontinue Taltz immediately if a serious hypersensitivity reaction occurs.
Symptom Monitoring
- Fever
- Chills
- Malaise
- Persistent cough
- Shortness of breath
- Painful urination
- New or worsening skin lesions
- Abdominal pain
- Diarrhea (especially bloody)
- Weight loss
- Rash
- Hives
- Swelling of face/lips/tongue/throat
- Difficulty breathing or swallowing
- Injection site reactions (redness, swelling, pain, bruising)
Special Patient Groups
Pregnancy
There are no adequate and well-controlled studies of Taltz in pregnant women. Human IgG antibodies are known to cross the placental barrier. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. A pregnancy exposure registry is available.
Trimester-Specific Risks:
First Trimester:
Limited data; potential for placental transfer of IgG antibodies.
Second Trimester:
Increased placental transfer of IgG antibodies occurs, especially in the third trimester.
Third Trimester:
Highest placental transfer of IgG antibodies; potential for fetal exposure and immunosuppression in the neonate. Consider delaying live vaccinations in infants exposed to Taltz in utero for at least 6 months after birth.
Lactation
It is not known whether ixekizumab is excreted in human milk. Human IgG is known to be excreted in human 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. Consider the half-life of ixekizumab (approximately 13 days).
Infant Risk:
L3 (Moderately Safe - Limited human data; potential for low levels in milk, but oral absorption by infant is likely minimal due to protein degradation in GI tract. Monitor for signs of infection or adverse effects.)
Pediatric Use
Approved for moderate to severe plaque psoriasis in patients 6 years of age and older. Safety and effectiveness in pediatric patients for other indications (PsA, AS, nr-axSpA) have not been established. Dosing is weight-based for pediatric plaque psoriasis.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly subjects (≥65 years) and younger subjects, but greater sensitivity of some older individuals cannot be ruled out. No dose adjustment is necessary based on age.
Clinical Information
Clinical Pearls
- Taltz is a highly effective biologic for moderate to severe plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and non-radiographic axial spondyloarthritis.
- Prior to initiation, screen patients for latent tuberculosis (TB) and Hepatitis B virus (HBV) infection. Treat latent TB before starting Taltz.
- Avoid live vaccines during Taltz treatment. Ensure patients are up-to-date on all age-appropriate immunizations before starting.
- Monitor patients for signs and symptoms of infection throughout treatment. Instruct patients to report any signs of infection immediately.
- Be aware of the risk of new onset or exacerbation of inflammatory bowel disease (IBD). Discontinue Taltz if IBD develops or worsens significantly.
- Patients can be taught to self-inject after proper training. Emphasize proper storage (refrigerated, protect from light, do not freeze or shake).
- Injection site reactions (erythema, pain, bruising) are common but usually mild and transient.
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)
- IL-23 inhibitors (e.g., guselkumab, risankizumab, tildrakizumab)
- Oral small molecules (e.g., apremilast, tofacitinib, deucravacitinib)
- Traditional systemic agents (e.g., methotrexate, cyclosporine, acitretin)
- Phototherapy
Cost & Coverage
Average Cost:
High (typically thousands of USD) per 80mg/ml autoinjector
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's essential to contact your doctor promptly. To ensure your safety, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which provides crucial information. Please read this guide carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, we encourage you to discuss them with 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 seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.