Siliq

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Brodalumab is injected under the skin. You may be shown how to use injections at home. Do not give yourself this medicine if you do not understand how to use the injection and properly dispose of used needles and syringes.

Brodalumab is usually given once a week for 3 weeks, and then once every 2 weeks thereafter. Follow your doctor's dosing instructions very carefully.

Read all instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Do not shake the medicine. Prepare your dose only when you are ready to give an injection. Do not use the medicine if it looks cloudy or has large particles in it. Call your pharmacist for new medicine.

Store prefilled syringes in their original container in the refrigerator. Protect from light and do not freeze.

Take the medicine out of the refrigerator and allow it to reach room temperature for 30 minutes before injecting your dose. Do heat the medicine in a microwave oven or place it into hot water. Leave the needle cap in place while the medicine warms to room temperature.

You may store a syringe for up to 14 days at room temperature. Keep the syringe in its original container and protect it from heat and light.

Any syringe warmed to room temperature should not be placed back into a refrigerator.

Each single-use prefilled syringe is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose.

Use a disposable needle and syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

Brodalumab can lower blood cells that help your body fight infections. You may get an infection more easily. Call your doctor if you have signs of infection such as fever, chills, flu symptoms, diarrhea, painful urination, and skin warmth or redness.

It may take several weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve after 12 weeks of using brodalumab.

Brodalumab comes with a Medication Guide and a Patient Wallet Card that lists the symptoms of a serious side effect. Read this information carefully and carry the Wallet Card with you at all times so you will know what symptoms to watch for.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Brodalumab is available only through a restricted program under a REMS called the Siliq REMS Program because of the observed suicidal ideation and behavior in subjects treated with brodalumab. Further information, including a list of qualified pharmacies, is available at or by calling the Siliq REMS Program Call Center at 855-511-6135.1

Use Siliq as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as a shot into the fatty part of the skin on the top of the thigh, belly area, or upper arm.
• If you will be giving yourself the shot, your doctor or nurse will teach you how to give the shot.
• Follow how to use as you have been told by the doctor or read the package insert.
• If stored in a refrigerator, let this medicine come to room temperature before using it. Leave it at room temperature for at least 30 minutes. Do not heat Siliq (brodalumab).
• Do not give into skin that is irritated, bruised, red, infected, or scarred.
• Do not give into skin that is affected by psoriasis.
• Do not shake.
• This medicine is colorless to a faint yellow. Do not use if the solution changes color.
• This product is clear but may contain a few particles. Do not use if the solution is cloudy, leaking, or has more than a few particles.
• Each prefilled syringe is for one use only.
• Throw away any part left over after the dose is given.
• Throw away needles in a needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow all local rules for getting rid of it. Talk with a doctor or pharmacist if you have any questions.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

Siliq™ is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies.

Suicidal Ideation and Behavior

Suicidal ideation and behavior, including 4 completed suicides, occurred in subjects treated with Siliq in the psoriasis clinical trials. There were no completed suicides in the 12-week placebo-controlled portion of the trials. Siliq users with a history of suicidality or depression had an increased incidence of suicidal ideation and behavior as compared to users without such a history [see Adverse Reactions (6.1)]. A causal association between treatment with Siliq and increased risk of suicidal ideation and behavior has not been established.

Prescribers should weigh the potential risks and benefits before using Siliq in patients with a history of depression or suicidality. Patients with new or worsening symptoms of depression or suicidality should be referred to a mental health professional, as appropriate. Advise patients and caregivers to seek medical attention for manifestations of suicidal ideation and behavior, new onset or worsening depression, anxiety, or other mood changes. Prescribers should also re-evaluate the risks and benefits of continuing treatment with Siliq if such events occur.

Because of the observed suicidal ideation and behavior in subjects treated with Siliq, if an adequate response to Siliq has not been achieved within 12 to 16 weeks, consider discontinuing therapy.

Siliq is available only through a restricted program under a REMS [see Warnings and Precautions (5.2)].

Siliq REMS Program

Siliq is available only through a restricted program under a REMS called the Siliq REMS Program because of the observed suicidal ideation and behavior in subjects treated with Siliq [see Warnings and Precautions (5.1)].

Notable requirements of the Siliq REMS Program include the following:

Further information, including a list of qualified pharmacies, is available at www.SiliqREMS.com or by calling the Siliq REMS Program Call Center at 855-511-6135.

Infections

Siliq may increase the risk of infections. In clinical trials, subjects treated with Siliq had a higher rate of serious infections than subjects treated with placebo (0.5% versus 0.2%) and higher rates of fungal infections (2.4% versus 0.9%). One case of cryptococcal meningitis occurred in a subject treated with Siliq during the 12-week randomized treatment period and led to discontinuation of therapy [see Adverse Reactions (6.1)].

During the course of clinical trials for plaque psoriasis, the exposure-adjusted rates for infections and serious infections were similar in the subjects treated with Siliq and those treated with ustekinumab.

In patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing Siliq. Instruct patients to seek medical help if signs or symptoms of clinically important chronic or acute infection occur. If a patient develops a serious infection or is not responding to standard therapy for the infection, monitor the patient closely and discontinue Siliq therapy until the infection resolves.

Risk for Latent Tuberculosis Reactivation

Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with Siliq. Do not administer Siliq to patients with active TB infection. Initiate treatment for latent TB prior to administering Siliq.

Consider anti-TB therapy prior to initiation of Siliq in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Closely monitor patients receiving Siliq for signs and symptoms of active TB during and after treatment.

Crohn’s Disease

In psoriasis trials, which excluded subjects with active Crohn’s disease, Crohn’s disease occurred in one subject during treatment with Siliq and led to discontinuation of therapy. In other trials, exacerbation of Crohn’s disease was observed with Siliq use.

Siliq is contraindicated in patients with Crohn’s disease.

Discontinue Siliq if the patient develops Crohn’s disease while taking Siliq.

Immunizations

Avoid use of live vaccines in patients treated with Siliq. No data are available on the ability of live or inactive vaccines to elicit an immune response in patients being treated with Siliq.

Pregnancy

Risk Summary

There are no human data on Siliq use in pregnant women to inform a drug associated risk. Human IgG antibodies are known to cross the placental barrier; therefore, Siliq may be transmitted from the mother to the developing fetus. In a combined embryofetal development and pre- and post-natal development study, no adverse developmental effects were observed in infants born to pregnant monkeys after subcutaneous administration of brodalumab during organogenesis through parturition at doses up to 26 times the maximum recommended human dose (MRHD) [see Data].

The estimated 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

A combined embryofetal development and pre- and post-natal development study was conducted in cynomolgus monkeys administered brodalumab. No brodalumab-related effects on embryofetal toxicity or malformations, or on morphological, functional or immunological development were observed in infants from pregnant monkeys administered weekly subcutaneous doses of brodalumab up to 26 times the MRHD from the beginning of organogenesis to parturition (on a mg/kg basis of 90 mg/kg/week).

Lactation

Risk Summary

There are no data on the presence of brodalumab in human milk, the effects on the breastfed infant, or the effects on milk production. Brodalumab 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 Siliq and any potential adverse effects on the breastfed infant from Siliq or from the underlying maternal condition.

Pediatric Use

The safety and effectiveness of Siliq have not been evaluated in pediatric patients.

Geriatric Use

Of the 3066 plaque psoriasis subjects initially randomized to Siliq in clinical trials, 192 (6%) were ≥ 65 years old and no subjects were ≥ 75 years old. Although no differences in safety or efficacy were observed between older and younger subjects, the number of subjects aged 65 years and older was not sufficient to determine whether they responded differently from younger subjects [see Clinical Pharmacology (12.3)].

NDC 0187-0004-02
Siliq
(brodalumab)
Injection
210 mg/1.5 mL

For Subcutaneous Use Only

Rx only

ATTENTION: Dispense with enclosed medication guide.

Some people have thoughts about suicide while taking Siliq. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor, such as mood changes, anxiety, or depression.

Siliq is available only from a certified pharmacy under a special program.

Other drugs may interact with brodalumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Applies to brodalumab: subcutaneous solution

Gastrointestinal

Common (1% to 10%): Diarrhea, oropharyngeal pain, nausea[Ref]

Hematologic

Common (1% to 10%): Neutropenia[Ref]

Genitourinary

Frequency not reported: Urinary tract infection[Ref]

Other

Common (1% to 10%): Fatigue[Ref]

Immunologic

Common (1% to 10%): Influenza, tinea infections (i.e., tinea pedis, tinea versicolor, tinea cruris), immunogenicity
Uncommon (0.1% to 1%): Candida infections (i.e., oral, genital, esophageal)[Ref]

Local

Common (1% to 10%): Injection site reactions (i.e., pain, erythema, bruising, hemorrhage, pruritus)[Ref]

Musculoskeletal

Common (1% to 10%): Arthralgia, myalgia[Ref]

Nervous system

Common (1% to 10%): Headache[Ref]

Ocular

Uncommon (0.1% to 1%): Conjunctivitis[Ref]

Respiratory

Frequency not reported: Nasopharyngitis, upper respiratory tract infection, pharyngitis, bronchitis[Ref]

Psychiatric

Uncommon (0.1% to 1%): Suicidal ideation or behavior[Ref]

Some side effects of Siliq may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.