Taltz 20mg/0.25ml Pf Syr, 0.25ml
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, Anti-inflammatory
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 the body. It works by blocking a specific protein called IL-17A, which is involved in causing inflammation in 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 skin on 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. 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 dose to minimize the risk of skin 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.
Discard any remaining medication after administration.
* Dispose of needles and other sharp objects in a designated container. Do not reuse needles or other items.
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. Protect the medication from light by storing it in its original container. If necessary, you may 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 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 dosing schedule. If the missed dose is near 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 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 skin on 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. 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 dose to minimize the risk of skin 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.
Discard any remaining medication after administration.
* Dispose of needles and other sharp objects in a designated container. Do not reuse needles or other items.
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. Protect the medication from light by storing it in its original container. If necessary, you may 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 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 dosing schedule. If the missed dose is near 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
- Avoid live vaccines while taking Taltz and for a period after stopping, as your immune system may be weakened.
- Report any signs of infection (e.g., fever, chills, persistent cough, skin sores) to your doctor immediately.
- 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 or 36°F to 46°F) in its original carton to protect from light. Do not freeze. Do not shake.
- Allow the syringe to reach room temperature for 30 minutes before injecting. Do not warm in any other way.
- Rotate injection sites (e.g., thigh, abdomen, upper arm) with each dose. Do not inject into skin that is tender, bruised, red, or hard.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
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 thereafter. Note: The 20mg/0.25ml formulation is primarily for pediatric use.
Dose Range:
80 - 160 mg
Condition-Specific Dosing:
Psoriatic Arthritis:
160 mg (two 80 mg injections) subcutaneously at Week 0, followed by 80 mg every 4 weeks. For patients with concomitant moderate to severe plaque psoriasis, the recommended dosing is 160 mg at Week 0, followed by 80 mg at Weeks 2, 4, 6, 8, 10, and 12, then 80 mg every 4 weeks.
Ankylosing Spondylitis:
160 mg (two 80 mg injections) subcutaneously at Week 0, followed by 80 mg every 4 weeks.
Non-radiographic Axial Spondyloarthritis:
160 mg (two 80 mg injections) subcutaneously at Week 0, followed by 80 mg every 4 weeks.
Erythrodermic 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 thereafter.
Generalized Pustular 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 thereafter.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
For Plaque Psoriasis (≥6 years of age and weighing ≥6 kg): Weight-based dosing. For patients weighing 6 kg to <25 kg: 20 mg every 4 weeks. For patients weighing 25 kg to <50 kg: 40 mg every 4 weeks. For patients weighing ≥50 kg: 80 mg every 4 weeks.
Adolescent:
For Plaque Psoriasis (≥6 years of age and weighing ≥6 kg): Weight-based dosing. For patients weighing 6 kg to <25 kg: 20 mg every 4 weeks. For patients weighing 25 kg to <50 kg: 40 mg every 4 weeks. For patients weighing ≥50 kg: 80 mg every 4 weeks.
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment necessary.
Moderate:
No dose adjustment necessary.
Severe:
No dose adjustment necessary.
Dialysis:
No specific recommendations; not expected to be removed by dialysis due to large molecular weight.
Hepatic Impairment:
Mild:
No dose adjustment necessary.
Moderate:
No dose adjustment necessary.
Severe:
No dose adjustment necessary.
Pharmacology
Mechanism of Action
Ixekizumab is a humanized IgG4 monoclonal antibody that selectively binds with high affinity to the cytokine interleukin 17A (IL-17A) 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:
7.1 L (central compartment)
ProteinBinding:
Not applicable (monoclonal antibody)
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 13 days
Clearance:
0.5 L/day
ExcretionRoute:
Metabolized and eliminated via protein degradation pathways; not renally or hepatically cleared in the traditional sense.
Unchanged:
Not applicable (biologic)
Pharmacodynamics
OnsetOfAction:
Within 2-4 weeks for clinical response in psoriasis.
PeakEffect:
Clinical response continues to improve over several weeks to months.
DurationOfAction:
Maintained with regular dosing (e.g., every 4 weeks).
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 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 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. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. 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
Signs of a common cold
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 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 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. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. 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
Signs of a common cold
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, cough, flu-like symptoms, warm/red/painful skin, open sores on your body.
- Symptoms of inflammatory bowel disease: new or worsening abdominal pain, diarrhea, rectal bleeding, weight loss.
- Signs of allergic reaction: rash, hives, swelling of your face, lips, tongue, or throat, difficulty breathing or swallowing.
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 supplements you are using
Vitamins you are taking
Any health problems you have
Before starting, stopping, or changing the dose of any medication, including this one, you must consult with your doctor to ensure your safety. 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 supplements you are using
Vitamins you are taking
Any health problems you have
Before starting, stopping, or changing the dose of any medication, including this one, you must consult with your doctor to ensure your safety. It is vital to verify that it is safe to take this medication with all your other medications and health conditions.
Precautions & Cautions
Important Warnings and Precautions 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 a history of inflammatory bowel disease, such as ulcerative colitis or Crohn's disease, discuss the potential risks and benefits with your doctor. This medication may exacerbate or trigger new cases of 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 during treatment, 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 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 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.
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 a history of inflammatory bowel disease, such as ulcerative colitis or Crohn's disease, discuss the potential risks and benefits with your doctor. This medication may exacerbate or trigger new cases of 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 during treatment, 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 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 treatment, consult with their doctor.
Overdose Information
Overdose Symptoms:
- No specific symptoms of overdose have been reported in clinical trials. Higher doses may increase the risk of adverse reactions, particularly infections.
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).
Drug Interactions
Contraindicated Interactions
- Live vaccines (e.g., BCG, measles, mumps, rubella, polio, rotavirus, yellow fever, varicella, zoster, smallpox)
Major Interactions
- Other immunosuppressants (e.g., cyclosporine, methotrexate, corticosteroids) - increased risk of infection
Monitoring
Baseline Monitoring
Tuberculosis (TB) screening
Rationale: To rule out latent or active TB infection before initiating treatment, as immunosuppression can reactivate latent TB.
Timing: Prior to initiation of therapy.
Hepatitis B and C virus screening
Rationale: Consider screening in patients with risk factors, as immunosuppression may reactivate viral hepatitis.
Timing: Prior to initiation of therapy (if risk factors present).
Complete Blood Count (CBC)
Rationale: General health assessment, although not specifically required for ixekizumab.
Timing: Prior to initiation of therapy.
Routine Monitoring
Signs and symptoms of infection
Frequency: Regularly throughout treatment and for several months after discontinuation.
Target: Absence of fever, chills, cough, sore throat, dysuria, skin lesions, etc.
Action Threshold: Prompt medical evaluation for any signs of serious infection.
Signs and symptoms of inflammatory bowel disease (IBD)
Frequency: Regularly throughout treatment.
Target: Absence of new or worsening abdominal pain, diarrhea, rectal bleeding, weight loss.
Action Threshold: Discontinue ixekizumab and refer to a gastroenterologist if new or worsening IBD symptoms occur.
Signs and symptoms of hypersensitivity reactions
Frequency: During and after injection.
Target: Absence of rash, urticaria, dyspnea, angioedema, anaphylaxis.
Action Threshold: Discontinue immediately and manage appropriately if severe reaction occurs.
Symptom Monitoring
- Fever
- Chills
- Persistent cough
- Shortness of breath
- Skin lesions (new or worsening)
- Sore throat
- Painful urination
- Unusual fatigue
- Abdominal pain
- Diarrhea
- Rectal bleeding
- Weight loss
- Rash
- Hives
- Swelling of face/lips/tongue/throat
- Difficulty breathing or swallowing
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; theoretical risk of immune system effects on the developing fetus.
Second Trimester:
Limited data; theoretical risk of immune system effects on the developing fetus.
Third Trimester:
Increased placental transfer of IgG antibodies occurs during the third trimester; theoretical risk of immune system effects on the developing fetus, particularly regarding immune response to live vaccines post-birth.
Lactation
It is unknown whether ixekizumab is excreted in human milk. Maternal IgG is known to be present 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. Due to its large molecular weight, transfer into breast milk is expected to be low, and oral absorption by the infant is unlikely.
Infant Risk:
Low risk. Monitor breastfed infants for signs of infection or adverse reactions.
Pediatric Use
Approved for the treatment of moderate to severe plaque psoriasis in pediatric patients aged 6 years and older who are candidates for systemic therapy or phototherapy. Dosing is weight-based. Safety and effectiveness in pediatric patients for other indications (e.g., psoriatic arthritis, ankylosing spondylitis) have not been established.
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. Monitor for increased risk of infections.
Clinical Information
Clinical Pearls
- Taltz is a biologic medication administered via subcutaneous injection. Proper injection technique and site rotation are crucial.
- Patients should be screened for tuberculosis (TB) before starting Taltz and monitored for signs of infection throughout treatment.
- Live vaccines are contraindicated during Taltz treatment. Patients should be up-to-date on all recommended immunizations prior to initiating therapy.
- Patients with a history of inflammatory bowel disease (IBD) should be monitored closely, as new onset or exacerbation of IBD has been reported.
- The 20mg/0.25ml prefilled syringe is specifically designed for weight-based pediatric dosing in plaque psoriasis.
Alternative Therapies
- Other IL-17 inhibitors (e.g., secukinumab, brodalumab)
- TNF inhibitors (e.g., adalimumab, etanercept, infliximab, certolizumab pegol, golimumab)
- IL-12/23 inhibitors (e.g., ustekinumab)
- IL-23 inhibitors (e.g., guselkumab, risankizumab, tildrakizumab)
- Oral small molecules (e.g., apremilast, tofacitinib)
- Traditional systemic agents (e.g., methotrexate, cyclosporine, acitretin)
- Phototherapy (e.g., UVB, PUVA)
Cost & Coverage
Average Cost:
Highly variable, typically several thousand USD per prefilled syringe
Insurance Coverage:
Specialty Tier (Tier 4 or higher), often requires prior authorization and step therapy.
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 consumed, and the time it occurred.