Scapho

Each vial of powder for solution for subcutaneous injection contains 150 mg of Scapho when reconstituted with 1 mL water for injection.

Each pre-filled syringe or pre-filled pen contains 150 mg Scapho.

Scapho is a recombinant fully human monoclonal antibody selective for interleukin-17A. Scapho is of the IgG1/κ-class produced in Chinese Hamster Ovary (CHO) cells.

Excipients: Powder for Solution for Subcutaneous Injection: Sucrose, L-histidine, L-histidine hydrochloride monohydrate, polysorbate 80, water for injection.

Solution for Injection (Pre-Filled Syringe and Pre-Filled Pen): Trehalose dihydrate, L-histidine/histidine hydrochloride monohydrate, L-methionine, polysorbate 80, water for injection.

​1.1 Plaque Psoriasis

Scapho® is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.

​1.2 Psoriatic Arthritis

​Scapho is indicated for the treatment of adult patients with active psoriatic arthritis.

​1.3 Ankylosing Spondylitis

​Scapho is indicated for the treatment of adult patients with active ankylosing spondylitis.

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

Scapho is used to treat moderate to severe plaque psoriasis (raised, silvery flaking of the skin), ankylosing spondylitis, and psoriatic arthritis in adults.

Scapho may also be used for purposes not listed in this medication guide.

​2.1 Plaque Psoriasis

The recommended dosage is 300 mg by subcutaneous injection at Weeks 0, 1, 2, 3, and 4 followed by 300 mg every 4 weeks. Each 300 mg dosage is given as 2 subcutaneous injections of 150 mg.

For some patients, a dosage of 150 mg may be acceptable.

​2.2 Psoriatic Arthritis

​For psoriatic arthritis patients with coexistent moderate to severe plaque psoriasis, use the dosing and administration recommendations for plaque psoriasis.

​For other psoriatic arthritis patients, administer Scapho with or without a loading dosage by subcutaneous injection. The recommended

Dosage:

• ​With a loading dosage is 150 mg at weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter
• ​Without a loading dosage is 150 mg every 4 weeks
• ​If a patient continues to have active psoriatic arthritis, consider a dosage of 300 mg.

​Scapho may be administered with or without methotrexate.

​2.3 Ankylosing Spondylitis

​Administer Scapho with or without a loading dosage by subcutaneous injection. The recommended

Dosage:

• ​With a loading dosage is 150 mg at weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter
• ​Without a loading dosage is 150 mg every 4 weeks

​2.4 Assessment Prior to Initiation of Scapho

​Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with Scapho.

2.5 Important Administration Instructions

There are three presentations for Scapho (i.e., Sensoready pen, prefilled syringe, and lyophilized powder in vial for reconstitution). The Scapho “Instructions for Use” for each presentation contains more detailed instructions on the preparation and administration of Scapho.

Scapho is intended for use under the guidance and supervision of a physician. Patients may self-inject after proper training in subcutaneous injection technique using the Sensoready pen or prefilled syringe and when deemed appropriate. The lyophilized powder for reconstitution is for healthcare provider use only. 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 Scapho in the upper, outer arm may be performed by a caregiver or healthcare provider.

2.6 Preparation for Use of Scapho Sensoready® Pen and Prefilled Syringe

Before injection, remove Scapho Sensoready pen or Scapho prefilled syringe from the refrigerator and allow Scapho to reach room temperature (15 to 30 minutes) without removing the needle cap.

The removable cap of the Scapho Sensoready pen and the Scapho prefilled syringe contains natural rubber latex and should not be handled by latex-sensitive individuals.

Inspect Scapho visually for particulate matter and discoloration prior to administration. Scapho injection is a clear to slightly opalescent, colorless to slightly yellow solution. Do not use if the liquid contains visible particles, is discolored or cloudy. Scapho does not contain preservatives; therefore, administer the Sensoready pen or prefilled syringe within 1 hour after removal from the refrigerator. Discard any unused product remaining in the Sensoready pen or prefilled syringe.

2.7 Reconstitution and Preparation of Scapho Lyophilized Powder

Scapho lyophilized powder should be prepared and reconstituted with Sterile Water for Injection by a trained healthcare provider using aseptic technique and without interruption. The preparation time from piercing the stopper until end of reconstitution on average takes 20 minutes and should not exceed 90 minutes.

a) Remove the vial of Scapho lyophilized powder from the refrigerator and allow to stand for 15 to 30 minutes to reach room temperature. Ensure the Sterile Water for Injection is at room temperature.

b) Slowly inject 1 mL of Sterile Water for Injection into the vial containing Scapho lyophilized powder and direct the stream of Sterile Water for Injection onto the lyophilized powder.

c) Tilt the vial at an angle of approximately 45 degrees and gently rotate between the fingertips for approximately 1 minute. Do not shake or invert the vial.

d) Allow the vial to stand for about 10 minutes at room temperature to allow for dissolution. Note that foaming may occur.

e) Tilt the vial at an angle of approximately 45 degrees and gently rotate between the fingertips for approximately 1 minute. Do not shake or invert the vial.

f) Allow the vial to stand undisturbed at room temperature for approximately 5 minutes. The reconstituted Scapho solution should be essentially free of visible particles, clear to opalescent, and colorless to slightly yellow. Do not use if the lyophilized powder has not fully dissolved or if the liquid contains visible particles, is cloudy or discolored.

g) Prepare the required number of vials (1 vial for the 150 mg dose or 2 vials for the 300 mg dose).

h) The Scapho reconstituted solution contains 150 mg of Scapho in 1 mL of solution. After reconstitution, use the solution immediately or store in the refrigerator at 2ºC to 8ºC (36ºF to 46ºF) for up to 24 hours. Do not freeze.

i) If stored at 2ºC to 8ºC (36ºF to 46ºF), allow the reconstituted Scapho solution to reach room temperature (15 to 30 minutes) before administration. Scapho does not contain preservatives; therefore, administer within 1 hour after removal from 2ºC to 8ºC (36ºF to 46ºF) storage.

See also:
What is the most important information I should know about Scapho?

Scapho is contraindicated in patients with a previous serious hypersensitivity reaction to Scapho or to any of the excipients.

Use Scapho as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Scapho comes with an extra patient information sheet called a Medication Guide. It also comes with an extra patient leaflet with detailed instructions for use. Read them carefully. Read them again each time you get Scapho refilled. Ask your doctor, nurse, or pharmacist any questions that you may have about this information.
• Scapho is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Scapho at home, a health care provider will teach you how to use it. Be sure you understand how to use Scapho. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
• Use the proper technique taught to you by your doctor. Inject deep under the skin, NOT into muscle or a vein.
• Injection sites within an injection area (stomach area or thighs; outer area of the upper arm if someone else is giving you Scapho) must be rotated from one injection to the next. Do not inject Scapho within 2 inches of the belly button. Do not inject Scapho into an area that is irritated, bruised, red, hard, infected, scarred, or has stretch marks.
• Before using Scapho, take it out of the refrigerator. Allow to reach room temperature (15 to 30 minutes) without taking off the needle cap. Do not heat Scapho.
• Do not shake Scapho. Scapho is colorless to light yellow. Do not use Scapho if it contains particles, is cloudy or discolored, or if the pen or syringe is cracked or damaged.
• Use Scapho within 1 hour after taking out of the refrigerator. After you use Scapho, throw away any medicine left in the pen or syringe.
• Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
• If you miss a dose of Scapho, call your doctor to find out what do.

Ask your health care provider any questions you may have about how to use Scapho.

Use: Labeled Indications

Ankylosing spondylitis: Treatment of active ankylosing spondylitis in adults.

Plaque psoriasis: Treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

Psoriatic arthritis: Treatment of active psoriatic arthritis in adults.

See also:
What other drugs will affect Scapho?

Drug interaction trials have not been conducted with Scapho.

Live Vaccines

Patients treated with Scapho may not receive live vaccinations.

Non-Live Vaccines

Patients treated with Scapho may receive non-live vaccinations. Healthy individuals who received a single 150 mg dose of Scapho 2 weeks prior to vaccination with a non-U.S. approved group C meningococcal polysaccharide conjugate vaccine and a non-U.S. approved inactivated seasonal influenza vaccine had similar antibody responses compared to individuals who did not receive Scapho prior to vaccination. The clinical effectiveness of meningococcal and influenza vaccines has not been assessed in patients undergoing treatment with Scapho.

CYP450 Substrates

A role for IL-17A in the regulation of CYP450 enzymes has not been reported. 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, Scapho, an antagonist of IL-17A, could normalize the formation of CYP450 enzymes. Upon initiation or discontinuation of Scapho in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic 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 Scapho?

The following adverse reactions are discussed in greater detail elsewhere in the labeling:

• Infections
• Inflammatory Bowel Disease
• Hypersensitivity Reactions

Clinical Trials Experience

Because clinical trials are conducted under widely varying 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.

Plaque Psoriasis

A total of 3430 plaque psoriasis subjects were treated with Scapho in controlled and uncontrolled clinical trials. Of these, 1641 subjects were exposed for at least 1 year.

Four placebo-controlled phase 3 trials in plaque psoriasis subjects were pooled to evaluate the safety of Scapho in comparison to placebo up to 12 weeks after treatment initiation, in Trials 1, 2, 3, and 4. In total, 2077 subjects were evaluated (691 to Scapho 300 mg group, 692 to Scapho 150 mg group, and 694 to placebo group).

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

Table 1 : Adverse Reactions Reported by Greater Than 1% of Subjects with Plaque Psoriasis Through Week 12 in Trials 1, 2, 3, and 4

Adverse reactions that occurred at rates less than 1% in the placebo-controlled period of Trials 1, 2, 3, and 4 through Week 12 included: sinusitis, tinea pedis, conjunctivitis, tonsillitis, oral candidiasis, impetigo, otitis media, otitis externa, inflammatory bowel disease, increased liver transaminases, and neutropenia.

Infections

In the placebo-controlled period of the clinical trials in plaque psoriasis (a total of 1382 subjects treated with Scapho and 694 subjects treated with placebo up to 12 weeks), infections were reported in 28.7% of subjects treated with Scapho compared with 18.9% of subjects treated with placebo. Serious infections occurred in 0.14% of patients treated with Scapho and in 0.3% of patients treated with placebo.

Over the entire treatment period (a total of 3430 plaque psoriasis subjects treated with Scapho for up to 52 weeks for the majority of subjects), infections were reported in 47.5% of subjects treated with Scapho (0.9 per patient-year of follow-up). Serious infections were reported in 1.2% of subjects treated with Scapho (0.015 per patient-year of follow-up).

Phase 3 data showed an increasing trend for some types of infection with increasing serum concentration of Scapho. Candida infections, herpes viral infections, staphylococcal skin infections, and infections requiring treatment increased as serum concentration of Scapho increased.

Neutropenia was observed in clinical trials. Most cases of Scapho-associated neutropenia were transient and reversible. No serious infections were associated with cases of neutropenia.

Inflammatory Bowel Disease

Cases of inflammatory bowel disease, in some cases serious, were observed in clinical trials with Scapho. In the plaque psoriasis program, with 3430 patients exposed to Scapho over the entire treatment period for up to 52 weeks (2,725 patient-years), there were 3 cases (0.11 per 100 patient-years) of exacerbation of Crohn's disease, 2 cases (0.08 per 100 patient-years) of exacerbation of ulcerative colitis, and 2 cases (0.08 per 100 patient-years) of new onset ulcerative colitis. There were no cases in placebo patients (N=793; 176 patient-years) during the 12 week placebo-controlled period.

One case of exacerbation of Crohn's disease was reported from long-term non-controlled portions of ongoing clinical trials in plaque psoriasis.

Hypersensitivity Reactions

Anaphylaxis and cases of urticaria occurred in Scapho treated patients in clinical trials.

Psoriatic Arthritis

Scapho was studied in two placebo controlled psoriatic arthritis trials with 1003 patients (703 patients on Scapho and 300 patients on placebo). Of the 703 patients who received Scapho, 299 patients received a subcutaneous loading dose of Scapho (PsA1) and 404 patients received an intravenous loading dose of Scapho (PsA2) followed by Scapho administered by subcutaneous injection every four weeks. During the 16-week placebo-controlled period of the trials in patients with psoriatic arthritis, the overall proportion of patients with adverse events was similar in the Scapho and placebo-treatment groups (59% and 58%, respectively). The adverse events that occurred at a proportion of at least 2% and at a higher proportion in the Scapho groups than the placebo groups during the 16week placebo-controlled period were nasopharyngitis, upper respiratory tract infection, headache, nausea, and hypercholesterolemia. The safety profile observed in patients with psoriatic arthritis treated with Scapho is consistent with the safety profile in psoriasis.

Similar to the clinical trials in patients with psoriasis, there was an increased proportion of patients with infections in the Scapho groups (29%) compared to placebo group (26%).

There were cases of Crohn's disease and ulcerative colitis that include patients who experienced either exacerbations or the development of new disease. There were three cases of inflammatory bowel disease, of which two patients received Scapho and one received placebo.

Ankylosing Spondylitis

Scapho was studied in two placebo controlled ankylosing spondylitis trials with 590 patients (394 patients on Scapho and 196 patients on placebo). Of the 394 patients who received Scapho, 145 patients received a subcutaneous load of Scapho (study AS1) and 249 received an intravenous loading dose of Scapho (study AS2) followed by Scapho administered by subcutaneous injection every four weeks. During the 16-week placebo-controlled period of the trials in patients with ankylosing spondylitis, the overall proportion of patients with adverse events was higher in the Scapho groups than the placebo-treatment groups (66% and 59%, respectively). The adverse events that occurred at a proportion of at least 2% and at a higher proportion in the Scapho groups than the placebo groups during the 16-week placebo-controlled period were nasopharyngitis, nausea, and upper respiratory tract infection. The safety profile observed in patients with ankylosing spondylitis treated with Scapho is consistent with the safety profile in psoriasis.

Similar to clinical trials in patients with psoriasis, there was an increased proportion of patients with infections in the Scapho groups (31%) compared to the placebo group (18%).

In the ankylosing spondylitis program, with 571 patients exposed to Scapho there were 8 cases of inflammatory bowel disease during the entire treatment period (5 Crohn's (0.7 per 100 patient-years) and 3 ulcerative colitis (0.4 per 100 patient-years)). During the placebo-controlled 16-week period, there were 2 Crohn's disease exacerbations and 1 new onset ulcerative colitis case that was a serious adverse event in patients treated with Scapho compared to none of the patients treated with placebo. During the remainder of the study when all patients received Scapho, 1 patient developed Crohn's disease, 2 patients had Crohn's exacerbations, 1 patient developed ulcerative colitis, and 1 patient had an ulcerative colitis exacerbation.

Immunogenicity

As with all therapeutic proteins, there is the potential for immunogenicity. The immunogenicity of Scapho was evaluated using an electrochemiluminescence-based bridging immunoassay. Less than 1% of subjects treated with Scapho developed antibodies to Scapho in up to 52 weeks of treatment. However, this assay has limitations in detecting anti-Scapho antibodies in the presence of Scapho; therefore the incidence of antibody development might not have been reliably determined. Of the subjects who developed antidrug antibodies, approximately one-half had antibodies that were classified as neutralizing. Neutralizing antibodies were not associated with loss of efficacy.

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 Scapho with the incidences of antibodies to other products may be misleading.