Taltz 40mg/0.5ml Pf Syr, 0.5ml
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-psoriatic, Anti-arthritic
Pharmacologic Class
Interleukin-17A (IL-17A) inhibitor, Monoclonal antibody
Pregnancy Category
Not available
FDA Approved
Mar 2016
DEA Schedule
Not Controlled
Overview
What is this medicine?
Taltz is an injectable 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, psoriatic arthritis, and certain types of spinal arthritis. By blocking this protein, Taltz helps improve skin symptoms, joint pain, and stiffness.
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 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 let it sit at room temperature for 30 minutes. Do not expose it 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.
Discard any remaining medication after use.
Dispose of needles and other sharp objects in a designated container. Do not reuse needles or other items. Follow local regulations for disposing of the container when it is full.
If you have vision problems, consider having someone else administer the injection. Consult with your doctor or pharmacist if you have any questions.
Storage and Disposal
Store this medication in the refrigerator at all times, except when removing it for use. Do not freeze the medication. If it has been frozen, do not use it. 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. If not used within 5 days, discard the medication.
Missing a Dose
If you miss a dose, take it as soon as you remember and resume your regular schedule. If it 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 extra doses. If you are unsure about what to do if you miss a 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 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 let it sit at room temperature for 30 minutes. Do not expose it 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.
Discard any remaining medication after use.
Dispose of needles and other sharp objects in a designated container. Do not reuse needles or other items. Follow local regulations for disposing of the container when it is full.
If you have vision problems, consider having someone else administer the injection. Consult with your doctor or pharmacist if you have any questions.
Storage and Disposal
Store this medication in the refrigerator at all times, except when removing it for use. Do not freeze the medication. If it has been frozen, do not use it. 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. If not used within 5 days, discard the medication.
Missing a Dose
If you miss a dose, take it as soon as you remember and resume your regular schedule. If it 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 extra doses. If you are unsure about what to do if you miss a dose, consult your doctor.
Lifestyle & Tips
- Avoid live vaccines while taking Taltz.
- Report any signs of infection (e.g., fever, chills, persistent cough) to your doctor immediately.
- Maintain good hygiene to reduce the risk of infection.
- Follow your doctor's instructions for proper injection technique and disposal of used syringes.
- Inform your healthcare provider about all medications, supplements, and herbal products you are taking.
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, followed by 80 mg every 4 weeks (Q4W). Psoriatic Arthritis, Ankylosing Spondylitis, Non-radiographic axial SpA: 160 mg (two 80 mg injections) at Week 0, then 80 mg every 4 weeks (Q4W). For PsA patients with coexistent moderate-to-severe plaque psoriasis, the psoriasis dosing regimen should be used.
Condition-Specific Dosing:
Plaque Psoriasis:
Initial 160 mg (two 80 mg injections) at Week 0, then 80 mg at Weeks 2, 4, 6, 8, 10, and 12, followed by 80 mg Q4W.
Psoriatic Arthritis:
Initial 160 mg (two 80 mg injections) at Week 0, then 80 mg Q4W. If coexistent moderate-to-severe plaque psoriasis, use plaque psoriasis regimen.
Ankylosing Spondylitis:
Initial 160 mg (two 80 mg injections) at Week 0, then 80 mg Q4W.
Non-radiographic axial Spondyloarthritis:
Initial 160 mg (two 80 mg injections) at Week 0, then 80 mg Q4W.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Plaque Psoriasis (≥6 years and ≥50 kg): 160 mg (two 80 mg injections) at Week 0, then 80 mg Q4W. Plaque Psoriasis (≥6 years and <50 kg): 80 mg at Week 0, then 40 mg Q4W.
Adolescent:
Plaque Psoriasis (≥6 years and ≥50 kg): 160 mg (two 80 mg injections) at Week 0, then 80 mg Q4W. Plaque Psoriasis (≥6 years and <50 kg): 80 mg at Week 0, then 40 mg Q4W.
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment recommended.
Moderate:
No dose adjustment recommended.
Severe:
No dose adjustment recommended.
Dialysis:
No specific considerations; not significantly cleared by kidneys.
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 and inhibits its interaction with the IL-17 receptor. IL-17A is a naturally occurring cytokine involved in inflammatory and immune responses. By blocking IL-17A, ixekizumab inhibits the release of pro-inflammatory cytokines and chemokines, thereby reducing inflammation and clinical symptoms associated with conditions like psoriasis and psoriatic arthritis.
Pharmacokinetics
Absorption:
Bioavailability:
54-90% (mean ~60-80%)
Tmax:
4-7 days
FoodEffect:
Not applicable (subcutaneous administration)
Distribution:
Vd:
Approximately 7.11 L (central compartment)
ProteinBinding:
Not applicable (monoclonal antibody)
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 13 days
Clearance:
Approximately 0.59 L/day
ExcretionRoute:
Catabolic degradation
Unchanged:
Not applicable (catabolized)
Pharmacodynamics
OnsetOfAction:
Clinical improvement observed as early as 2-4 weeks.
PeakEffect:
Varies by clinical endpoint, typically by 12-16 weeks.
DurationOfAction:
Sustained with regular Q4W dosing.
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 or seek immediate 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 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:
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. For medical advice about side effects, contact 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 immediate 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 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:
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. For medical advice about side effects, contact 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, persistent cough, shortness of breath, fatigue, body aches.
- Signs of severe allergic reaction: rash, hives, swelling of the face, lips, tongue, or throat, difficulty breathing or swallowing.
- New or worsening symptoms of inflammatory bowel disease (IBD): persistent abdominal pain, diarrhea, bloody stools, weight loss.
- Unusual bruising or bleeding.
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, 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 it is safe to take this medication in conjunction 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, 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 it is safe to take this medication in conjunction 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 a history of inflammatory bowel disease, such as ulcerative colitis or Crohn's disease, discuss this 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 potential 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 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 this 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 potential 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 treatment, consult with their doctor.
Overdose Information
Overdose Symptoms:
- No specific symptoms of overdose have been reported in clinical trials.
- In case of overdose, monitor for any signs or symptoms of adverse reactions.
What to Do:
There is no specific antidote for ixekizumab. Management of overdose should include general supportive measures and symptomatic treatment. Call 1-800-222-1222 (Poison Control) or seek emergency medical attention.
Drug Interactions
Contraindicated Interactions
- Live vaccines (e.g., BCG, measles, mumps, rubella, polio, rotavirus, yellow fever, varicella, zoster, typhoid)
Major Interactions
- Live vaccines (increased risk of infection)
- Other immunosuppressants (e.g., cyclosporine, methotrexate, corticosteroids) - increased risk of infection, though often used in combination with conventional DMARDs for PsA.
Monitoring
Baseline Monitoring
Tuberculosis (TB) screening
Rationale: To rule out latent or active TB infection before initiating immunosuppressive therapy.
Timing: Prior to initiation of Taltz.
Hepatitis B and C screening
Rationale: To assess for chronic viral hepatitis, which may be reactivated with immunosuppression.
Timing: Prior to initiation, especially in patients with risk factors.
Assessment for signs/symptoms of infection
Rationale: To ensure patient is free of active infection before starting treatment.
Timing: Prior to initiation.
Routine Monitoring
Signs and symptoms of infection (e.g., fever, chills, persistent cough, fatigue)
Frequency: Regularly throughout treatment
Target: Absence of signs/symptoms
Action Threshold: Prompt medical evaluation if signs/symptoms of infection develop.
Signs and symptoms of inflammatory bowel disease (IBD) (e.g., new or worsening abdominal pain, diarrhea, bloody stools)
Frequency: Regularly throughout treatment
Target: Absence of new or worsening IBD symptoms
Action Threshold: Prompt medical evaluation if IBD symptoms develop or worsen; consider discontinuation if severe.
Injection site reactions
Frequency: After each injection
Target: Minimal or no reaction
Action Threshold: Monitor for severity; advise patient on management; consider alternative injection sites.
Hypersensitivity reactions
Frequency: After each injection and throughout treatment
Target: Absence of allergic reactions
Action Threshold: Discontinue immediately and manage appropriately if severe allergic reaction occurs.
Symptom Monitoring
- Fever
- Chills
- Persistent cough
- Shortness of breath
- Fatigue
- Skin rash
- Hives
- Swelling of face, lips, tongue, or throat
- Difficulty breathing or swallowing
- Abdominal pain
- Diarrhea
- Bloody stools
- Joint pain or swelling (for efficacy monitoring)
Special Patient Groups
Pregnancy
Limited human data on ixekizumab use in pregnant women are insufficient to inform a drug-associated risk for major birth defects or miscarriage. IgG antibodies are known to cross the placental barrier; therefore, ixekizumab may be transferred from the mother to the developing fetus. Use only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Risk unknown; large molecule, but placental transfer increases with gestational age.
Second Trimester:
Risk unknown; placental transfer increases with gestational age.
Third Trimester:
Potential for increased fetal exposure due to higher placental transfer of IgG antibodies during the third trimester. Monitor infants for signs of infection if exposed in utero.
Lactation
No data are available on the presence of ixekizumab in human milk, the effects on the breastfed infant, or the effects on milk production. 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.
Infant Risk:
Low risk is generally expected for large molecule biologics due to minimal transfer into milk and likely degradation in the infant's gastrointestinal tract, but human data are lacking.
Pediatric Use
Approved for moderate-to-severe plaque psoriasis in pediatric patients aged 6 years and older who are candidates for systemic therapy or phototherapy. Safety and efficacy for other indications (PsA, AS, nr-axSpA) have not been established in pediatric patients.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly (≥65 years) and younger patients in clinical trials. However, greater sensitivity of some older individuals cannot be ruled out. No specific dose adjustment is required based on age.
Clinical Information
Clinical Pearls
- Taltz is administered via subcutaneous injection. Patients or caregivers can be trained to administer the injection at home.
- Do not inject into areas where the skin is tender, bruised, red, scaly, or hard. Rotate injection sites.
- Patients should be evaluated for tuberculosis (TB) infection prior to initiating treatment with Taltz.
- Monitor patients for signs and symptoms of infection during and after treatment. Discontinue Taltz if a serious infection develops.
- Taltz may exacerbate inflammatory bowel disease (IBD) or cause new onset IBD. Monitor for new or worsening IBD symptoms.
- Avoid concomitant use of live vaccines with Taltz.
- Store Taltz in the refrigerator (2°C to 8°C / 36°F to 46°F) in the original carton to protect from light. Do not freeze. Do not shake.
Alternative Therapies
- Other IL-17 inhibitors (e.g., secukinumab, brodalumab)
- IL-23 inhibitors (e.g., guselkumab, risankizumab, tildrakizumab)
- TNF-alpha inhibitors (e.g., adalimumab, etanercept, infliximab, certolizumab pegol, golimumab)
- IL-12/23 inhibitors (e.g., ustekinumab)
- Oral small molecules (e.g., apremilast, tofacitinib, upadacitinib, deucravacitinib)
- Conventional systemic therapies (e.g., methotrexate, cyclosporine, acitretin)
Cost & Coverage
Average Cost:
Highly variable, typically several thousand USD per syringe
Insurance Coverage:
Specialty Tier, typically requires prior authorization and step therapy by most insurance plans.
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 is a valuable patient fact sheet. 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, 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 reporting the incident, be prepared to provide detailed information, including the substance taken, the amount, and the time it occurred.