Taltz 80mg/ml Pf Syr, 1ml
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
Immunosuppressants, Antipsoriatics, Anti-rheumatics
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 medication that helps reduce inflammation in the body. It works by blocking a specific protein called IL-17A, which plays a role in causing inflammation in conditions like psoriasis and psoriatic arthritis. By blocking this protein, Taltz can help improve skin symptoms, reduce joint pain and swelling, and improve overall physical function.
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, abdominal 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 tissue damage.
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 the 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. If you have visual impairment, consider having someone assist you with administering the injection.
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, abdominal 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 tissue damage.
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 the 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. If you have visual impairment, consider having someone assist you with administering the injection.
Lifestyle & Tips
- Avoid live vaccines while on Taltz and consult your doctor before receiving any vaccinations.
- Report any signs of infection (e.g., fever, chills, persistent cough, flu-like symptoms) to your doctor immediately.
- Maintain good hygiene to reduce the risk of infections.
- 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 of IBD.
- Store Taltz in the refrigerator (2°C to 8°C or 36°F to 46°F) and protect from light. Do not freeze. Do not shake.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Plaque Psoriasis: Initial 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: Initial 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 (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.
Psoriatic Arthritis:
Initial 160 mg (two 80 mg injections) at Week 0, then 80 mg every 4 weeks. For patients with coexistent moderate to severe plaque psoriasis, the plaque psoriasis dosing regimen should be used.
Ankylosing Spondylitis:
Initial 160 mg (two 80 mg injections) at Week 0, then 80 mg every 4 weeks.
Non-radiographic axial Spondyloarthritis:
Initial 160 mg (two 80 mg injections) at Week 0, then 80 mg every 4 weeks.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Plaque Psoriasis (≥6 years and ≥50 kg): Initial 160 mg (two 80 mg injections) at Week 0, then 80 mg every 4 weeks. Plaque Psoriasis (≥6 years and <50 kg): Initial 80 mg at Week 0, then 40 mg every 4 weeks. Psoriatic Arthritis (≥6 years): Dosing based on weight, similar to plaque psoriasis.
Adolescent:
Plaque Psoriasis (≥6 years and ≥50 kg): Initial 160 mg (two 80 mg injections) at Week 0, then 80 mg every 4 weeks. Plaque Psoriasis (≥6 years and <50 kg): Initial 80 mg at Week 0, then 40 mg every 4 weeks. Psoriatic Arthritis (≥6 years): Dosing based on weight, similar to plaque psoriasis.
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 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:
54-90%
Tmax:
4-7 days
FoodEffect:
No significant effect
Distribution:
Vd:
7.1 L
ProteinBinding:
Not applicable (large protein)
CnssPenetration:
Limited
Elimination:
HalfLife:
13 days
Clearance:
0.5 L/day
ExcretionRoute:
Catabolism
Unchanged:
Not applicable (protein degradation)
Pharmacodynamics
OnsetOfAction:
Within 2-4 weeks
PeakEffect:
Varies by indication, often by 12-16 weeks
DurationOfAction:
Maintained with every 4-week dosing due to long half-life
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. 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
Common cold symptoms
This is not an exhaustive list of possible side effects. If you have questions or concerns, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical help right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Some patients with severe allergic reactions may require hospitalization.
Signs of infection, including:
+ Fever
+ Chills
+ Severe sore throat
+ Ear or sinus pain
+ Cough
+ Increased or 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. 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
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, persistent cough, shortness of breath, flu-like symptoms, warm/red/painful skin lesions.
- New or worsening symptoms of inflammatory bowel disease: persistent abdominal pain, diarrhea, rectal bleeding, weight loss.
- Signs of allergic reaction: rash, hives, swelling of the face, lips, tongue, or throat, difficulty breathing or swallowing, dizziness, feeling faint.
- 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 is not an exhaustive list of all potential interactions with this medication. Therefore, it is crucial to discuss the following with your doctor and pharmacist:
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins.
Any existing health problems or conditions.
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. Never start, stop, or adjust the dose of any medication without first consulting 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 all potential interactions with this medication. Therefore, it is crucial to discuss the following with your doctor and pharmacist:
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins.
Any existing health problems or conditions.
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. Never start, stop, or adjust the dose of any medication without first consulting your doctor.
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 during treatment, as some vaccines may increase the risk of infection or reduce their effectiveness when used in conjunction 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 the 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 during treatment, as some vaccines may increase the risk of infection or reduce their effectiveness when used in conjunction 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 the 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 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
Major Interactions
- Live vaccines (e.g., BCG, measles, mumps, rubella, polio, rotavirus, yellow fever, varicella, zoster)
Moderate Interactions
- Other immunosuppressants (e.g., cyclosporine, methotrexate, corticosteroids - increased risk of infection, though often used in combination)
- Non-live vaccines (may reduce immune response)
Monitoring
Baseline Monitoring
Tuberculosis (TB) screening
Rationale: To rule out latent or active TB infection before initiating immunosuppressive therapy.
Timing: Prior to initiation of treatment
Hepatitis B and C screening
Rationale: To assess for chronic viral hepatitis, which may be reactivated with immunosuppression.
Timing: Prior to initiation of treatment
Complete Blood Count (CBC)
Rationale: To establish baseline hematologic parameters, though significant hematologic effects are rare.
Timing: Prior to initiation of treatment
Liver Function Tests (LFTs)
Rationale: To establish baseline liver function, though significant hepatotoxicity is rare.
Timing: Prior to initiation of treatment
Routine Monitoring
Signs and symptoms of infection
Frequency: Regularly, at each visit
Target: Absence of infection
Action Threshold: Prompt evaluation and treatment if infection suspected
Signs and symptoms of inflammatory bowel disease (IBD)
Frequency: Regularly, at each visit
Target: Absence of new or worsening IBD symptoms
Action Threshold: Discontinue ixekizumab and refer to gastroenterologist if new or worsening IBD symptoms occur
Hypersensitivity reactions
Frequency: Regularly, at each visit and patient education for self-monitoring
Target: Absence of allergic reactions
Action Threshold: Discontinue ixekizumab immediately if serious allergic reaction occurs
Injection site reactions
Frequency: Regularly, at each visit and patient education for self-monitoring
Target: Mild or absent reactions
Action Threshold: Manage symptomatically; consider alternative injection sites or technique if severe/persistent
Symptom Monitoring
- Fever
- Chills
- Persistent cough
- Shortness of breath
- Fatigue
- Skin lesions (new or worsening)
- New or worsening abdominal pain
- Diarrhea
- Rectal bleeding
- Severe rash
- Swelling of face, lips, tongue, or throat
- Difficulty breathing or swallowing
- Dizziness
- Injection site pain, redness, swelling, or itching
Special Patient Groups
Pregnancy
Pregnancy Category Not Assigned. Limited data from clinical trials and post-marketing experience are insufficient to inform a drug-associated risk for major birth defects and miscarriage. Human IgG antibodies are known to cross the placental barrier; therefore, ixekizumab may be transferred from the mother to the developing fetus. 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 is lower in early pregnancy.
Second Trimester:
Potential for placental transfer increases as pregnancy progresses.
Third Trimester:
Highest potential for placental transfer of IgG antibodies, which could lead to immunosuppression in the infant.
Lactation
Limited data 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 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.
Infant Risk:
Low to unknown. Due to its large molecular weight, absorption of intact ixekizumab by the infant is unlikely. However, potential for local effects in the infant's gut cannot be excluded. Monitor breastfed infants for signs of infection.
Pediatric Use
Approved for plaque psoriasis and psoriatic arthritis in patients 6 years of age and older. Safety and effectiveness in pediatric patients less than 6 years of age have not been established.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly patients (≥65 years) and younger adult patients in clinical trials. However, greater sensitivity of some older individuals cannot be ruled out. No dose adjustment is necessary based on age.
Clinical Information
Clinical Pearls
- Prior to initiating Taltz, evaluate patients for tuberculosis (TB) infection. Taltz should not be given to patients with active TB. Initiate treatment of latent TB prior to administering Taltz.
- Patients should be advised to avoid live vaccines during Taltz treatment.
- Monitor patients for signs and symptoms of infection during and after treatment. If a serious infection develops, discontinue Taltz until the infection resolves.
- New onset or exacerbation of inflammatory bowel disease (Crohn's disease and ulcerative colitis) has been reported. Monitor patients for IBD symptoms.
- Injection site reactions are common but usually mild to moderate. Proper injection technique and rotating injection sites can help minimize these reactions.
- Taltz is a biologic and should be handled carefully; do not shake the prefilled syringe or autoinjector.
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, guselkumab, risankizumab)
- 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:
High (typically several thousand USD) per 80mg/ml prefilled syringe
Insurance Coverage:
Specialty Tier (requires prior authorization, step therapy, or other restrictions)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, a patient fact sheet that provides important information. Please read it carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, don't hesitate 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. Be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred, to help healthcare professionals provide the best possible care.
This medication is accompanied by a Medication Guide, a patient fact sheet that provides important information. Please read it carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, don't hesitate 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. Be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred, to help healthcare professionals provide the best possible care.