Taltz 80mg

Taltz 80mg™ is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

Taltz 80mg (Taltz 80mg) is an immunosuppressant that reduces the effects of a chemical substance in the body that can cause inflammation.

Taltz 80mg is used to treat moderate to severe plaque psoriasis (raised, silvery flaking of the skin) in adults.

Taltz 80mg may also be used for purposes not listed in this medication guide.

Dosage

Taltz 80mg is administered by subcutaneous injection. The recommended dose is 160 mg (two 80 mg injections) at Week 0, followed by 80 mg at Weeks 2, 4, 6, 8, 10, and 12, then 80 mg every 4 weeks.

Tuberculosis Assessment Prior To Initiation Of Taltz 80mg

Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with Taltz 80mg.

Important Administration Instructions

There are two presentations for Taltz 80mg (i.e., autoinjector and prefilled syringe). The Taltz 80mg “Instructions for Use” for each presentation contains more detailed instructions on the preparation and administration of Taltz 80mg.

Taltz 80mg is intended for use under the guidance and supervision of a physician. Patients may self-inject after training in subcutaneous injection technique using the autoinjector or prefilled syringe. Administer each injection at a different anatomic location (such as upper arms, thighs or any quadrant of abdomen) than the previous injection, and not into areas where the skin is tender, bruised, erythematous, indurated or affected by psoriasis. Administration of Taltz 80mg in the upper, outer arm may be performed by a caregiver or healthcare provider.

If a dose is missed, administer the dose as soon as possible. Thereafter, resume dosing at the regular scheduled time.

Preparation For Use Of Taltz 80mg And Prefilled Syringe

Before injection, remove Taltz 80mg or Taltz 80mg prefilled syringe from the refrigerator and allow Taltz 80mg to reach room temperature (30 minutes) without removing the needle cap.

Inspect Taltz 80mg visually for particulate matter and discoloration prior to administration. Taltz 80mg is a clear and colorless to slightly yellow solution. Do not use if the liquid contains visible particles, is discolored or cloudy (other than clear and colorless to slightly yellow). Taltz 80mg does not contain preservatives, therefore discard any unused product remaining in the autoinjector or prefilled syringe.

Instruct patients using the autoinjector or prefilled syringe to inject the full amount (1 mL), which provides 80 mg of Taltz 80mg, according to the directions provided in the Instructions for Use.

How supplied

Dosage Forms And Strengths

Taltz 80mg is a clear and colorless to slightly yellow solution available as:

Autoinjector

• Injection: 80 mg/mL solution of Taltz 80mg in a single-dose prefilled autoinjector

Prefilled Syringe

• Injection: 80 mg/mL solution of Taltz 80mg in a single-dose prefilled syringe

Taltz 80mg injection is a sterile, preservative free, clear and colorless to slightly yellow solution available in a singledose prefilled autoinjector or a single-dose prefilled syringe to deliver 80 mg Taltz 80mg.

Taltz 80mg is supplied as:

Storage And Handling

Taltz 80mg is sterile and preservative-free. Discard any unused portion.

• Taltz 80mg must be protected from light until use.
• Store refrigerated at 2°C to 8°C (36°F to 46°F).
• Do not freeze. Do not use Taltz 80mg if it has been frozen.
• Do not shake.
• Discard the Taltz 80mg single-dose autoinjector or syringe after use in a puncture-resistant container.
• Not made with natural rubber latex.

Eli Lilly and Company Indianapolis, IN 46285, USA. Revised: March 2016

See also:
What is the most important information I should know about Taltz 80mg?

Taltz 80mg is contraindicated in patients with a previous serious hypersensitivity reaction, such as anaphylaxis, to Taltz 80mg or to any of the excipients.

This medication is used to treat plaque psoriasis. Taltz 80mg belongs to a class of drugs known as monoclonal antibodies. It works by blocking a certain natural protein in your body (interleukin-17A) that may cause inflammation and swelling.

How to use Taltz 80mg (3 Pack) subcutaneous

Read the Medication Guide and Instructions for Use provided by your pharmacist before you start using Taltz 80mg and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Before treatment with this medication, your doctor will test you for tuberculosis (TB). Your doctor should also monitor you for symptoms of TB during and after treatment with this drug. If needed, treatment for tuberculosis or other infections should be given before receiving this medication.

This medication is given by injection under your skin as directed by your doctor. The injection is given in the upper arms, thighs, or abdomen (at least 1 inch from your belly button). The dosage is based on your medical condition and response to treatment. Follow your doctor's instructions carefully.

If you are using this medication at home, learn all preparation and usage instructions from your health care professional and the product instructions. Wash your hands before using this medication. Remove the medication from the refrigerator 30 minutes before you inject it to allow it to reach room temperature. Do not warm up this medication any other way such as by heating in the microwave, placing in hot water, or leaving it in direct sunlight. Do not shake the medication. The medication should be clear or slightly yellow. Before using, check this product visually for cloudiness, particles, or discoloration. If you see any of these things, do not use the liquid. Before injecting each dose, clean the injection site with rubbing alcohol. Change the injection site each time to lessen injury under the skin. Do not inject into skin that is irritated, sore, bruised, red, hard, or affected by psoriasis. To lessen bruising, do not rub the injection site after a shot. Learn how to store and discard medical supplies safely. Do not reuse syringes.

Use this medication regularly to get the most benefit from it. It may help to mark your calendar with a reminder.

Tell your doctor if your condition does not get better or if it gets worse.

See also:
What other drugs will affect Taltz 80mg?

Live Vaccinations

Avoid use of live vaccines in patients treated with Taltz 80mg.

Cytochrome P450 Substrates

The formation of CYP450 enzymes can be altered by increased levels of certain cytokines (e.g., IL-1, IL-6, IL-10, TNFα, IFN) during chronic inflammation. Thus, Taltz 80mg, an antagonist of IL-17A, could normalize the formation of CYP450 enzymes.

Therefore, upon initiation or discontinuation of Taltz 80mg in patients who are receiving concomitant drugs which are CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for effect (e.g., for warfarin) or drug concentration (e.g., for cyclosporine) and consider dosage modification of the CYP450 substrate.

See also:
What are the possible side effects of Taltz 80mg?

The following adverse drug reactions are discussed in greater detail in other sections of the label:

• Infections
• Hypersensitivity Reactions
• Inflammatory Bowel Disease

Clinical Trials Experience

Because clinical trials are conducted under widely varying and controlled conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Weeks 0 To 12

Three placebo-controlled trials in subjects with plaque psoriasis were integrated to evaluate the safety of Taltz 80mg compared to placebo for up to 12 weeks. A total of 1167 subjects (mean age 45 years; 66% men; 94% White) with plaque psoriasis received Taltz 80mg (160 mg at Week 0, 80 mg every two weeks [Q2W] for 12 weeks) subcutaneously. In two of the trials, the safety of Taltz 80mg (use up to 12 weeks) was also compared with an active comparator, U.S. approved etanercept.

In the 12-week, placebo-controlled period, adverse events occurred in 58% of the Taltz 80mg Q2W group (2.5 per subject-year of follow-up) compared with 47% of the placebo group (2.1 per subject-year of follow-up). Serious adverse events occurred in 2% of the Taltz 80mg group (0.07 per subject-year of follow-up), and in 2% of the placebo group (0.07 per subject-year of follow-up).

Table 1 summarizes the adverse reactions that occurred at a rate of at least 1% and at a higher rate in the Taltz 80mg group than in the placebo group during the 12-week placebo-controlled period of the pooled clinical trials.

Table 1: Adverse Reactions Occurring in ≥ 1% of the Taltz 80mg Group and More Frequently than in the Placebo Group in the Plaque Psoriasis Clinical Trials through Week 12

Adverse reactions that occurred at rates less than 1% in the Taltz 80mg group and more frequently than in the placebo group during the 12-week induction period included rhinitis, oral candidiasis, urticaria, influenza, conjunctivitis, inflammatory bowel disease, and angioedema.

Weeks 13 To 60

A total of 332 subjects received the recommended maintenance regimen of Taltz 80mg 80 mg dosed every 4 weeks.

During the maintenance period (Weeks 13 to 60), adverse events occurred in 80% of subjects treated with Taltz 80mg (1.0 per subject-year of follow-up) compared to 58% of subjects treated with placebo (1.1 per subject-year of follow-up). Serious adverse events were reported in 4% of subjects treated with Taltz 80mg (0.05 per subject-year of follow-up) and none in the subjects treated with placebo.

Weeks 0 To 60

Over the entire treatment period (Weeks 0 to 60), adverse events were reported in 67% of subjects treated with Taltz 80mg (1.4 per subject-year of follow-up) compared to 48% of subjects treated with placebo (2.0 per subject-year of follow-up). Serious adverse events were reported in 3% of subjects treated with Taltz 80mg (0.06 per subject-year of followup), and in 2% of subjects treated with placebo (0.06 per subject-year of follow-up).

Specific Adverse Drug Reactions

Injection Site Reactions

The most frequent injection site reactions were erythema and pain. Most injection site reactions were mild-tomoderate in severity and did not lead to discontinuation of Taltz 80mg.

Infections

In the 12-week, placebo-controlled period of the clinical trials in plaque psoriasis, infections occurred in 27% of subjects treated with Taltz 80mg (1.2 per subject-year of follow-up) compared to 23% of subjects treated with placebo (1.0 per subject-year of follow-up). Serious infections occurred in 0.4% of subjects treated with Taltz 80mg (0.02 per subject-year of follow-up) and in 0.4% of subjects treated with placebo (0.02 per subject-year of follow-up).

During the maintenance treatment period (Weeks 13 to 60), infections occurred in 57% of subjects treated with Taltz 80mg (0.70 per subject-year of follow-up) compared to 32% of subjects treated with placebo (0.61 per subject-year of follow-up). Serious infections occurred in 0.9% of subjects treated with Taltz 80mg (0.01 per subject-year of follow-up) and none in the subjects treated with placebo.

Over the entire treatment period (Weeks 0 to 60), infections were reported in 38% of subjects treated with Taltz 80mg (0.83 per subject-year of follow-up) compared to 23% of subjects treated with placebo (1.0 per subject-year of follow-up). Serious infections occurred in 0.7% of subjects treated with Taltz 80mg (0.02 per subject-year of follow-up), and in 0.4% of subject treated with placebo (0.02 per subject-year of follow-up).

Laboratory Assessment of Cytopenia

Neutropenia

Over the entire treatment period (Weeks 0 to 60), neutropenia occurred in 11% of subjects treated with Taltz 80mg (0.24 per subject-year of follow-up) compared to 3% of subjects treated with placebo (0.14 per subject-year of follow-up). In subjects treated with Taltz 80mg, the incidence rate of neutropenia during Weeks 13 to 60 was lower than the incidence rate during Weeks 0 to 12.

In the 12-week, placebo-controlled period, neutropenia ≥ Grade 3 ( < 1,000 cells/mm³) occurred in 0.2% of the Taltz 80mg group (0.007 per subject-year of follow-up) compared to 0.1% of the placebo group (0.006 per subject-year of follow-up). The majority of cases of neutropenia were either Grade 2 (2% for Taltz 80mg 80 mg Q2W versus 0.3% for placebo; ≥ 1,000 to < 1,500 cells/mm³) or Grade 1 (7% for Taltz 80mg 80 mg Q2W versus 3% for placebo; ≥ 1,500 cells/mm³ to < 2,000 cells/mm³). Neutropenia in the Taltz 80mg group was not associated with an increased rate of infection compared to the placebo group.

Thrombocytopenia

Ninety eight percent of cases of thrombocytopenia were Grade 1 (3% for Taltz 80mg 80 mg Q2W versus 1% for placebo; ≥ 75,000 cells/mm³ to < 150,000 cells/ mm³). Thrombocytopenia in subjects treated with Taltz 80mg was not associated with an increased rate of bleeding compared to subjects treated with placebo.

Active Comparator Trials

In the two clinical trials that included an active comparator, the rate of serious adverse events during weeks zero to twelve was 0.7% for U.S. approved etanercept and 2% for Taltz 80mg 80 mg Q2W, and the rate of discontinuation from adverse events was 0.7% for U.S. approved etanercept and 2% for Taltz 80mg 80 mg Q2W. The incidence of infections was 18% for U.S. approved etanercept and 26% for Taltz 80mg 80 mg Q2W. The rate of serious infections was 0.3% for both Taltz 80mg 80 mg Q2W and U.S. approved etanercept.

Immunogenicity

As with all therapeutic proteins there is the potential for immunogenicity with Taltz 80mg. By Week 12, approximately 9% of subjects treated with Taltz 80mg every 2 weeks developed antibodies to Taltz 80mg. Approximately 22% of subjects treated with Taltz 80mg at the recommended dosing regimen developed antibodies to Taltz 80mg during the 60-week treatment period. The clinical effects of antibodies to Taltz 80mg are dependent on the antibody titer; higher antibody titers were associated with decreasing drug concentration and clinical response.

Of the subjects who developed antibodies to Taltz 80mg during the 60-week treatment period, approximately 10%, which equates to 2% of subjects treated with Taltz 80mg at the recommended dosing regimen, had antibodies that were classified as neutralizing. Neutralizing antibodies were associated with reduced drug concentrations and loss of efficacy.

However, the assay to test for neutralizing antibodies has limitations detecting neutralizing antibodies in the presence of Taltz 80mg; therefore, the incidence of neutralizing antibodies development could be underestimated.

The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of incidence of antibodies to Taltz 80mg with the incidences of antibodies to other products may be misleading.