planning stage [1):<1) Adverse reactions that occurred at rates less than 1% in the Taltz 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 80 mg dosed every 4 weeks. During the maintenance period (Weeks 13 to 60), adverse events occurred in 80% of subjects treated with Taltz (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 (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 (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 (0.06 per subject-year of follow-up), 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-to-moderate in severity and did not lead to discontinuation of Taltz. Infections In the 12-week, placebo-controlled period of the clinical trials in plaque psoriasis, infections occurred in 27% of subjects treated with Taltz (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 (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) [see Warnings and Precautions ( 5.1 )] . During the maintenance treatment period (Weeks 13 to 60), infections occurred in 57% of subjects treated with Taltz (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 (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 (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 (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 (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, 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/mm 3 ) occurred in 0.2% of the Taltz 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 80 mg Q2W versus 0.3% for placebo; 1,000 to> <1,500 cells/mm 3 ) or Grade 1 (7% for Taltz 80 mg Q2W versus 3% for placebo; 1,500 cells/mm 3 to 2,000 cells/mm 3 ). Neutropenia in the Taltz 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 80 mg Q2W versus 1% for placebo; 75,000 cells/mm 3 to> <150,000 cells/mm 3 ). Thrombocytopenia in subjects treated with Taltz 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 80 mg Q2W, and the rate of discontinuation from adverse events was 0.7% for U.S. approved etanercept and 2% for Taltz 80 mg Q2W. The incidence of infections was 18% for U.S. approved etanercept and 26% for Taltz 80 mg Q2W. The rate of serious infections was 0.3% for both Taltz 80 mg Q2W and U.S. approved etanercept. Immunogenicity As with all therapeutic proteins there is the potential for immunogenicity with Taltz. By Week 12, approximately 9% of subjects treated with Taltz every 2 weeks developed antibodies to ixekizumab. Approximately 22% of subjects treated with Taltz at the recommended dosing regimen developed antibodies to ixekizumab during the 60-week treatment period. The clinical effects of antibodies to ixekizumab 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 ixekizumab during the 60-week treatment period, approximately 10%, which equates to 2% of subjects treated with Taltz 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 ixekizumab; 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 with the incidences of antibodies to other products may be misleading. Postmarketing Experience The following adverse reactions have been identified during post-approval use of Taltz. Because the reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to Taltz exposure. Immune system disorders: anaphylaxis [see Contraindication ( 4 ) and Warnings and Precautions ( 5.3 )] . Drug Interactions Live Vaccinations Avoid use of live vaccines in patients treated with Taltz [see Warnings and Precautions ( 5.5 )] . 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, an antagonist of IL-17A, could normalize the formation of CYP450 enzymes. Therefore, upon initiation or discontinuation of Taltz 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. USE IN SPECIFIC POPULATIONS Pregnancy Risk Summary There are no available data on Taltz use in pregnant women to inform any drug associated risks. Human IgG is known to cross the placental barrier; therefore, Taltz may be transmitted from the mother to the developing fetus. An embryofetal development study conducted in pregnant monkeys at doses up to 19 times the maximum recommended human dose (MRHD) revealed no evidence of harm to the developing fetus. When dosing was continued until parturition, neonatal deaths were observed at 1.9 times the MRHD [see Data ] . The clinical significance of these nonclinical findings is unknown. The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data An embryofetal development study was conducted in cynomolgus monkeys administered ixekizumab. No malformations or embryofetal toxicity were observed in fetuses from pregnant monkeys administered ixekizumab weekly by subcutaneous injection during organogenesis to near parturition at doses up to 19 times the MRHD (on a mg/kg basis of 50 mg/kg/week). Ixekizumab crossed the placenta in monkeys. In a pre- and post-natal development toxicity study, pregnant cynomolgus monkeys were administered weekly subcutaneous doses of ixekizumab up to 19 times the MRHD from the beginning of organogenesis to parturition. Neonatal deaths occurred in the offspring of two monkeys administered ixekizumab at 1.9 times the MRHD (on a mg/kg basis of 5 mg/kg/week) and two monkeys administered ixekizumab at 19 times the MRHD (on a mg/kg basis of 50 mg/kg/week). These neonatal deaths were attributed to early delivery, trauma, or congenital defect. The clinical significance of these findings is unknown. No ixekizumab-related effects on functional or immunological development were observed in the infants from birth through 6 months of age. Lactation Risk Summary There are no data on the presence of ixekizumab in human milk, the effects on the breastfed infant, or the effects on milk production. Ixekizumab was detected in the milk of lactating cynomolgus monkeys. 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. Pediatric Use The safety and effectiveness of Taltz in pediatric patients (> <18 years of age) have not been evaluated. Geriatric Use Of the 4204 psoriasis subjects exposed to Taltz, a total of 301 were 65 years or older, and 36 subjects were 75 years or older. Although no differences in safety or efficacy were observed between older and younger subjects, the number of subjects aged 65 and over is not sufficient to determine whether they respond differently from younger subjects [see Clinical Pharmacology ( 12.3 )] . Overdosage In the event of overdosage, monitor the patient for any signs or symptoms of adverse reactions and institute appropriate symptomatic treatment immediately. Taltz Description Ixekizumab is a humanized immunoglobulin G subclass 4 (IgG4) monoclonal antibody (mAb) with neutralizing activity against IL-17A. Ixekizumab is produced by recombinant DNA technology in a recombinant mammalian cell line and purified using standard technology for bioprocessing. Ixekizumab is comprised of two identical light chain polypeptides of 219 amino acids each and two identical heavy chain polypeptides of 445 amino acids each, and has a molecular weight of 146,158 Daltons for the protein backbone of the molecule. Taltz injection is a sterile, preservative free, clear and colorless to slightly yellow solution, for subcutaneous use available as 80 mg of ixekizumab in a 1 mL single-dose prefilled autoinjector or a single-dose prefilled syringe. The prefilled autoinjector and prefilled syringe each contain a 1 mL glass syringe with a fixed 27 gauge inch needle. The Taltz 80 mg prefilled autoinjector and prefilled syringe are manufactured to deliver 80 mg of ixekizumab. Each mL is composed of ixekizumab (80 mg); Citric Acid Anhydrous, USP (0.51 mg); Polysorbate 80, USP (0.3 mg); Sodium Chloride, USP (11.69 mg); Sodium Citrate Dihydrate, USP (5.11 mg); and Water for Injection, USP. The Taltz solution has a pH of 5.3 6.1. Taltz - Clinical Pharmacology Mechanism of Action Ixekizumab is a humanized IgG4 monoclonal antibody that selectively binds with 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 proinflammatory cytokines and chemokines. Pharmacodynamics No formal pharmacodynamic studies have been conducted with Taltz. Pharmacokinetics Absorption Following a single subcutaneous dose of 160 mg in subjects with plaque psoriasis, ixekizumab reached peak mean ( SD) serum concentrations (C max ) of 16.2 6.6 mcg/mL by approximately 4 days post dose. Steady-state concentrations were achieved by Week 8 following the 160 mg starting dose and 80 mg every 2 weeks dosing regimen; the mean SD steady-state trough concentration was 9.3 5.3 mcg/mL. Steady-state concentrations were achieved approximately 10 weeks after switching from the 80 mg every 2 weeks dosing regimen to the 80 mg every 4 weeks dosing regimen at Week 12. The mean SD steady-state trough concentration was 3.5 2.5 mcg/mL. In studies of subjects with plaque psoriasis, ixekizumab bioavailability ranged from 60% to 81% following subcutaneous injection. Administration of ixekizumab via injection in the thigh achieved a higher bioavailability relative to that achieved using other injection sites including the arm and abdomen. Distribution The mean (geometric CV%) volume of distribution at steady-state was 7.11 L (29%) in subjects with plaque psoriasis. Elimination The metabolic pathway of ixekizumab has not been characterized. As a humanized IgG4 monoclonal antibody ixekizumab is expected to be degraded into small peptides and amino acids via catabolic pathways in the same manner as endogenous IgG. The mean systemic clearance was 0.39 L/day (37%) and the mean (geometric CV%) half-life was 13 days (40%) in subjects with plaque psoriasis. Weight Ixekizumab clearance and volume of distribution increase as body weight increases. Dose Linearity Ixekizumab exhibited dose-proportional pharmacokinetics in subjects with plaque psoriasis over a dose range from 5 mg (not the recommended dose) to 160 mg following subcutaneous administration. Specific Populations Age: Geriatric Population Population pharmacokinetic analysis indicated that age did not significantly influence the clearance of ixekizumab in adult subjects with plaque psoriasis. Subjects who are 65 years or older had a similar ixekizumab clearance as compared to subjects less than 65 years old. Renal or Hepatic Impairment No formal trial of the effect of hepatic or renal impairment on the pharmacokinetics of ixekizumab was conducted. Drug Interaction Studies Drug interaction studies have not been conducted with Taltz. Nonclinical Toxicology Carcinogenesis, Mutagenesis, Impairment of Fertility Animal studies have not been conducted to evaluate the carcinogenic or mutagenic potential of Taltz. Moreover published literature is mixed on potential effects on malignancy risk due to the inhibition of IL-17A activity, the pharmacological action of Taltz. Some published literature suggests that IL-17A directly promotes cancer cell invasion, suggesting a potential beneficial effect by Taltz, whereas other reports indicate IL-17A promotes T-cell mediated tumor rejection, suggesting a potential adverse effect by Taltz. However, neutralization of IL-17A with Taltz has not been studied in these models. Depletion of IL-17A with a neutralizing antibody inhibited tumor development in mice, suggesting a potential beneficial effect by Taltz. The relevance of experimental findings in mouse models for malignancy risk in humans is unknown. No effects on fertility parameters such as reproductive organs, menstrual cycle length, or sperm analysis were observed in sexually mature cynomolgus monkeys that were administered ixekizumab for 13 weeks at a subcutaneous dose of 50 mg/kg/week (19 times the MRHD on a mg/kg basis). The monkeys were not mated to evaluate fertility. Clinical Studies Three multicenter, randomized, double-blind, placebo-controlled trials (Trials 1, 2, and 3) enrolled a total of 3866 subjects 18 years of age and older with plaque psoriasis who had a minimum body surface area involvement of 10%, a static Physician Global Assessment (sPGA) score of 3 in the overall assessment (plaque thickness/induration, erythema, and scaling) of psoriasis on a severity scale of 0 to 5, a Psoriasis Area and Severity Index (PASI) score 12, and who were candidates for phototherapy or systemic therapy. In all three trials, subjects were randomized to either placebo or Taltz (80 mg every two weeks [Q2W]) for 12 weeks, following a 160 mg starting dose. In the two active comparator trials (Trials 2 and 3), subjects were also randomized to receive U.S. approved etanercept 50 mg twice weekly for 12 weeks. All three trials assessed the changes from baseline to Week 12 in the two co-primary endpoints: 1) PASI 75, the proportion of subjects who achieved at least a 75% reduction in the PASI composite score that takes into consideration both the percentage of body surface area affected and the nature and severity of psoriatic changes (induration, erythema and scaling) within the affected regions, and 2) sPGA of 0 (clear) or 1 (minimal), the proportion of subjects with an sPGA 0 or 1 and at least a 2-point improvement. Other evaluated outcomes included the proportion of subjects with an sPGA score of 0 (clear), a reduction of at least 90% in PASI (PASI 90), a reduction of 100% in PASI (PASI 100), and an improvement of itch severity as measured by a reduction of at least 4 points on an 11-point itch Numeric Rating Scale. Subjects in all treatment groups had a median baseline PASI score ranging from approximately 17 to 18. Baseline sPGA score was severe or very severe in 51% of subjects in Trial 1, 50% in Trial 2, and 48% in Trial 3. Of all subjects, 44% had received prior phototherapy, 49% had received prior conventional systemic therapy, and 26% had received prior biologic therapy for the treatment of psoriasis. Of the subjects who had received prior biologic therapy, 15% had received at least one anti-TNF alpha agent, and 9% had received an anti-IL 12/IL23. A total of 23% of study subjects had a history of psoriatic arthritis. Clinical Response at Week 12 The results of Trials 1, 2, and 3 are presented in Table 2 . Table 2: Efficacy Results at Week 12 in Adults with Plaque Psoriasis in Trials 1, 2, and 3; NRI a a Abbreviations: N = number of patients in the intent-to-treat population; NRI = Non-Responder Imputation. b Co-primary endpoints. c At Week 0, subjects received 160 mg of Taltz. Trial 1 Trial 2 Trial 3 Taltz 80 mg c Q2W (N=433) n (%) Placebo (N=431) n (%) Taltz 80 mg c Q2W (N=351) n (%) Placebo (N=168) n (%) Taltz 80 mg c Q2W (N=385) n (%) Placebo (N=193) n (%) sPGA of 0 (clear) or 1 (minimal) b 354 (82) 14 (3) 292 (83) 4 (2) 310 (81) 13 (7) sPGA of 0 (clear) 160 (37) 0 147 (42) 1 (1) 155 (40) 0 PASI 75 b 386 (89) 17 (4) 315 (90) 4 (2) 336 (87) 14 (7) PASI 90 307 (71) 2 (1) 248 (71) 1 (1) 262 (68) 6 (3) PASI 100 153 (35) 0 142 (40) 1 (1) 145 (38) 0 Examination of age, gender, race, body weight, and previous treatment with a biologic did not identify differences in response to Taltz among these subgroups at Week 12. Subjects treated with Taltz 80 mg Q2W experienced improvement in itch severity when compared to placebo at Week 12. An integrated analysis of the U.S. sites in the two active comparator studies using U.S. approved etanercept, Taltz demonstrated superiority to U.S. approved etanercept (50 mg twice weekly) on sPGA and PASI scores during the 12 week treatment period. The respective response rates for Taltz 80 mg Q2W and U.S. approved etanercept 50 mg twice weekly were: sPGA of 0 or 1 (73% and 27%); PASI 75 (87% and 41%); sPGA of 0 (34% and 5%); PASI 90 (64% and 18%), and PASI 100 (34% and 4%). Maintenance and Durability of Response To evaluate the maintenance and durability of response, subjects originally randomized to Taltz and who were responders at Week 12 (i.e., sPGA of 0 or 1) in Trial 1 and Trial 2 were re-randomized to an additional 48 weeks of either a maintenance dose of Taltz 80 mg Q4W (every four weeks) or placebo. Non-responders (sPGA> 1) at Week 12 and subjects who relapsed (sPGA 3) during the maintenance period were placed on Taltz 80 mg Q4W. For responders at Week 12, the percentage of subjects who maintained this response (sPGA 0 or 1) at Week 60 (48 weeks following re-randomization) in the integrated trials (Trial 1 and Trial 2) was higher for subjects treated with Taltz 80 mg Q4W (75%) compared to those treated with placebo (7%). For responders at Week 12 who were re-randomized to treatment withdrawal (i.e., placebo), the median time to relapse (sPGA 3) was 164 days in the integrated trials. Among these subjects, 66% regained a response of at least 0 or 1 on the sPGA within 12 weeks of restarting treatment with Taltz 80 mg Q4W. How Supplied/Storage and Handling How Supplied Taltz injection is a sterile, preservative free, clear and colorless to slightly yellow solution available in a single-dose prefilled autoinjector or a single-dose prefilled syringe to deliver 80 mg ixekizumab. Taltz is supplied as: Pack Size NDC Code Autoinjector 80 mg single-dose Carton of 1 0002-1445-11 80 mg single-dose Carton of 2 0002-1445-27 80 mg single-dose Carton of 3 0002-1445-09 Prefilled syringe 80 mg single-dose Carton of 1 0002-7724-11 80 mg single-dose Carton of 2 0002-7724-27 80 mg single-dose Carton of 3 0002-7724-09 Storage and Handling Taltz is sterile and preservative-free. Discard any unused portion. Taltz 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 if it has been frozen. Do not shake. Discard the Taltz single-dose autoinjector or syringe after use in a puncture-resistant container. Not made with natural rubber latex. Patient Counseling Information Advise the patient and/or caregiver to read the FDA-approved patient labeling ( Medication Guide and Instructions for Use ) before the patient starts using Taltz, and each time the prescription is renewed, as there may be new information they need to know. Instructions on Self-Administration : Provide guidance to patients and caregivers on proper subcutaneous injection technique, including aseptic technique, and how to use the autoinjector or prefilled syringe correctly [see Instructions for Use ] . Infection : Inform patients that Taltz may lower the ability of their immune system to fight infections. Instruct patients of the importance of communicating any history of infections to the healthcare provider, and contacting their healthcare provider if they develop any symptoms of infection [see Warnings and Precautions ( 5.1 )] . Allergic Reactions : Advise patients to seek immediate medical attention if they experience any symptoms of serious hypersensitivity reactions [see Warnings and Precautions ( 5.3 )] . Eli Lilly and Company, Indianapolis, IN 46285, USA US License Number 1891 Product of Ireland Copyright 2016, 2017, Eli Lilly and Company. All rights reserved. TAL-0003-USPI-20170705 This Medication Guide has been approved by the U.S. Food and Drug Administration. Issued: March 2016 Medication Guide Taltz (tȯl(t)s) (ixekizumab) injection, for subcutaneous use What is the most important information I should know about Taltz? Taltz is a medicine that affects your immune system. Taltz may lower the ability of your immune system to fight infections and may increase your risk of infections, which can sometimes become serious. Your healthcare provider should check you for tuberculosis (TB) before you start treatment with Taltz. Your healthcare provider may treat you with medicine for TB before you begin treatment with Taltz if you have a past history of TB or have TB. Your healthcare provider should watch you closely for signs and symptoms of TB during and after treatment with Taltz. Before starting Taltz, tell your healthcare provider if you: are being treated for an infection have an infection that does not go away or that keeps coming back have TB or have been in close contact with someone with TB think you have an infection or have symptoms of an infection such as: fever, sweats, or chills muscle aches cough shortness of breath blood in your phlegm (mucus) weight loss warm, red, or painful skin or sores on your body diarrhea or stomach pain burning when you urinate or urinate more often than normal After starting Taltz, call your healthcare provider right away if you have any of the symptoms of infection listed above. Do not use Taltz if you have any symptoms of infection unless you are instructed to by your healthcare provider. See What are the possible side effects of Taltz? for more information about side effects. What is Taltz? Taltz is a prescription medicine used to treat adults: with moderate to severe plaque psoriasis, and who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet or UV light) It is not known if Taltz is safe and effective in children under 18 years of age. Do not use Taltz if you have had a severe allergic reaction to ixekizumab or any of the other ingredients in Taltz. See the end of this Medication Guide for a complete list of ingredients in Taltz. Before using Taltz, tell your healthcare provider about all of your medical conditions, including if you: have any of the conditions or symptoms listed in the section What is the most important information I should know about Taltz? have Crohn's disease or ulcerative colitis have recently received or are scheduled to receive an immunization (vaccine). You should avoid receiving live vaccines during treatment with Taltz. are pregnant or plan to become pregnant. It is not known if Taltz can harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if Taltz passes into your breast milk. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. How should I use Taltz? See the detailed Instructions for Use that comes with your Taltz for information on how to prepare and inject a dose of Taltz, and how to properly throw away (dispose of) used Taltz autoinjectors and prefilled syringes. Use Taltz exactly as prescribed by your healthcare provider. If your healthcare provider decides that you or a caregiver may give your injections of Taltz at home, you should receive training on the right way to prepare and inject Taltz. Do not try to inject Taltz yourself, until you or your caregiver have been shown how to inject Taltz. Taltz comes in an autoinjector and a prefilled syringe that you or your caregiver may use at home to give injections. Your healthcare provider will decide which type of Taltz is best for you to use at home. Taltz is given as an injection under your skin (subcutaneous injection), in your thighs or stomach area (abdomen) by you or a caregiver. A caregiver may also give you an injection of Taltz in the back of your arm. Do not give an injection in an area of the skin that is tender, bruised, red or hard, or in an area of skin that is affected by psoriasis. Each Taltz injection should be given at an alternate site. Do not use the 1 inch area around your navel (belly button). If you forget to take your dose: Do not miss any doses of Taltz unless your healthcare provider says it is okay. If you forget to take your Taltz dose, inject a dose as soon as you remember. Then, take your next dose at your regular scheduled time. If you inject more Taltz than prescribed, call your healthcare provider or go to the nearest emergency room right away. What are the possible side effects of Taltz? Taltz may cause serious side effects, including: See What is the most important information I should know about Taltz? Serious allergic reactions. If you have a severe allergic reaction, do not give another injection of Taltz. Get emergency medical help right away if you get any of the following symptoms of a serious allergic reaction: feel faint swelling of your face, eyelids, lips, mouth, tongue, or throat trouble breathing or throat tightness chest tightness skin rash Crohn's disease or ulcerative colitis (Inflammatory bowel disease) can happen during treatment with Taltz, including worsening symptoms . Tell your healthcare provider if you have new or worsening symptoms of inflammatory bowel disease during treatment with Taltz, including: stomach (abdomen) pain diarrhea with or without blood weight loss The most common side effects of Taltz include: injection site reactions upper respiratory infections nausea fungal infections These are not all of the possible side effects of Taltz. Tell your healthcare provider about any side effect that bothers you or that does not go away. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should I store Taltz? Store Taltz in the refrigerator between 36 F to 46 F (2 C to 8 C). Protect Taltz from light. Do not freeze Taltz. Do not use if Taltz has been frozen. Do not shake Taltz. Keep Taltz and all medicines out of the reach of children. General information about the safe and effective use of Taltz. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Taltz for a condition for which it was not prescribed. Do not give Taltz to other people, even if they have the same symptoms you have. It may harm them. You can ask your healthcare provider or pharmacist for information about Taltz that is written for health professionals. What are the ingredients in Taltz? Active ingredient: ixekizumab Inactive ingredients: Citric Acid Anhydrous, Polysorbate 80, Sodium Chloride, Sodium Citrate Dihydrate, and Water for Injection Not made with natural rubber latex. For more information about Taltz, call 1-800-545-5979 (1-800-LillyRx) or go to the following website: www.Taltz.com. Taltz (ixekizumab) injection is a registered trademark of Eli Lilly and Company. Eli Lilly and Company Indianapolis, IN 46285, USA, US License Number 1891, Product of Ireland Copyright 2016, Eli Lilly and Company. All rights reserved. TAL-0001-MG-20160322 INSTRUCTIONS FOR USE Taltz (tȯl(t)s) (ixekizumab) injection, for subcutaneous use Autoinjector Before you use the Taltz autoinjector, read and carefully follow all the step-by-step instructions. Important information: Your healthcare provider or nurse should show you how to prepare and inject Taltz using the autoinjector. Do not inject yourself or someone else until you have been shown how to inject Taltz. You and your caregiver should read this Instructions for Use before you start using Taltz and each time you get a refill. Keep the Instructions for Use and refer to them as needed. Each Taltz autoinjector contains 1 dose of Taltz. The autoinjector is for one-time use only. The autoinjector contains glass parts. Handle autoinjector carefully. If you drop it on a hard surface, do not use it. Use a new Taltz autoinjector for your injection. Your healthcare provider may help you decide where on your body to inject your dose. Do not give an injection in an area of the skin that is tender, bruised, red or hard, or in an area of skin that is affected by psoriasis. Read the Choose your injection site section of these instructions to help you choose which area can work best for you. If you have vision or hearing problems, do not use Taltz autoinjector without help from a caregiver. INSTRUCTIONS FOR USE Before you use the Taltz autoinjector, read and carefully follow all the step-by-step instructions. Parts of the Taltz autoinjector 1 Get Ready 1a Take the Taltz autoinjector from the refrigerator. Remove the autoinjector from the package. Put the original package with any unused autoinjectors back in the refrigerator. Leave the base cap on until you are ready to inject. Wait 30 minutes to let the autoinjector warm to room temperature before you use it. Do not microwave the autoinjector, run hot water over it, or leave it in direct sunlight. Do not shake the autoinjector. 1b Gather the supplies needed for your injection: 1 alcohol wipe 1 cotton ball or piece of gauze 1 sharps disposal container. See Dispose of the used autoinjector. 1c Inspect the autoinjector. Make sure the name Taltz appears on the label. The medicine inside should be clear. Its color may be colorless to slightly yellow. Do not use the autoinjector, and dispose of as directed by your healthcare provider or pharmacist if: the expiration date printed o to collapse
venture Taltz equipment
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