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Brodalumab

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Overview

What is Siliq?

Brodalumab is a human monoclonal IgG2κ antibody directed against human interleukin-17 receptor A (IL-17RA). It is expressed in a Chinese Hamster Ovary (CHO) cell line. Brodalumab is comprised of 1312 amino acids and has an estimated molecular mass of 144,000 Daltons.

SILIQ (brodalumab) Injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution, delivered via subcutaneous injection. A few translucent to white, amorphous particles may be present. SILIQ is supplied in a single-dose 2.25 mL syringe made from type 1 glass with stainless steel 27G x ½" needle. Each SILIQ single-dose prefilled syringe delivers 1.5 mL of solution containing 210 mg of brodalumab formulated in glutamate (6.5 mg), polysorbate 20 (0.15 mg), proline (36 mg), and Water for Injection, USP at pH 4.8.



What does Siliq look like?



What are the available doses of Siliq?

Injection: 210 mg/1.5 mL solution in a single-dose prefilled syringe. SILIQ is a clear to slightly opalescent, colorless to slightly yellow solution and may contain a few translucent to white, amorphous particles .

What should I talk to my health care provider before I take Siliq?

How should I use Siliq?

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.

The recommended SILIQ dose is 210 mg administered by subcutaneous injection at Weeks 0, 1, and 2 followed by 210 mg every 2 weeks.

If an adequate response has not been achieved after 12 to 16 weeks of treatment with SILIQ, consider discontinuing therapy. Continued treatment beyond 16 weeks in patients who have not achieved an adequate response is not likely to result in greater success.


What interacts with Siliq?

Sorry No Records found


What are the warnings of Siliq?

Sorry No Records found


What are the precautions of Siliq?

Sorry No Records found


What are the side effects of Siliq?

Sorry No records found


What should I look out for while using Siliq?

SILIQ is contraindicated in patients with Crohn’s disease because SILIQ may cause worsening of disease


What might happen if I take too much Siliq?

Sorry No Records found


How should I store and handle Siliq?

Lovastatin Tablets, USP are available as follows:10 mg — Each white, round, flat faced beveled edge tablet debossed with on one side and 633 on the other side contains 10 mg of lovastatin, USP. Tablets are supplied in bottles of 60 (NDC 45963-633-01) and 500 (NDC 45963-633-04).20 mg — Each pink, round, flat faced beveled edge tablet debossed with on one side and 634 on the other side contains 20 mg of lovastatin, USP. Tablets are supplied in bottles of 60 (NDC 45963-634-01) and 500 (NDC 45963-634-04).40 mg — Each yellow, round, flat faced beveled edge tablet debossed with on one side and 635 on the other side contains 40 mg of lovastatin, USP. Tablets are supplied in bottles of 60 (NDC 45963-635-01) and 500 (NDC 45963-635-04).Dispense in a tight, light-resistant container as defined in the USP.Store between 5° to 25°C (41° to 77°F). Protect from light and store in a well-closed, light-resistant container.Manufactured by:Actavis Elizabeth LLCElizabeth, NJ 07207 USADistributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USA40-9186Revised – March  2017Lovastatin Tablets, USP are available as follows:10 mg — Each white, round, flat faced beveled edge tablet debossed with on one side and 633 on the other side contains 10 mg of lovastatin, USP. Tablets are supplied in bottles of 60 (NDC 45963-633-01) and 500 (NDC 45963-633-04).20 mg — Each pink, round, flat faced beveled edge tablet debossed with on one side and 634 on the other side contains 20 mg of lovastatin, USP. Tablets are supplied in bottles of 60 (NDC 45963-634-01) and 500 (NDC 45963-634-04).40 mg — Each yellow, round, flat faced beveled edge tablet debossed with on one side and 635 on the other side contains 40 mg of lovastatin, USP. Tablets are supplied in bottles of 60 (NDC 45963-635-01) and 500 (NDC 45963-635-04).Dispense in a tight, light-resistant container as defined in the USP.Store between 5° to 25°C (41° to 77°F). Protect from light and store in a well-closed, light-resistant container.Manufactured by:Actavis Elizabeth LLCElizabeth, NJ 07207 USADistributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USA40-9186Revised – March  2017Lovastatin Tablets, USP are available as follows:10 mg — Each white, round, flat faced beveled edge tablet debossed with on one side and 633 on the other side contains 10 mg of lovastatin, USP. Tablets are supplied in bottles of 60 (NDC 45963-633-01) and 500 (NDC 45963-633-04).20 mg — Each pink, round, flat faced beveled edge tablet debossed with on one side and 634 on the other side contains 20 mg of lovastatin, USP. Tablets are supplied in bottles of 60 (NDC 45963-634-01) and 500 (NDC 45963-634-04).40 mg — Each yellow, round, flat faced beveled edge tablet debossed with on one side and 635 on the other side contains 40 mg of lovastatin, USP. Tablets are supplied in bottles of 60 (NDC 45963-635-01) and 500 (NDC 45963-635-04).Dispense in a tight, light-resistant container as defined in the USP.Store between 5° to 25°C (41° to 77°F). Protect from light and store in a well-closed, light-resistant container.Manufactured by:Actavis Elizabeth LLCElizabeth, NJ 07207 USADistributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USA40-9186Revised – March  2017Lovastatin Tablets, USP are available as follows:10 mg — Each white, round, flat faced beveled edge tablet debossed with on one side and 633 on the other side contains 10 mg of lovastatin, USP. Tablets are supplied in bottles of 60 (NDC 45963-633-01) and 500 (NDC 45963-633-04).20 mg — Each pink, round, flat faced beveled edge tablet debossed with on one side and 634 on the other side contains 20 mg of lovastatin, USP. Tablets are supplied in bottles of 60 (NDC 45963-634-01) and 500 (NDC 45963-634-04).40 mg — Each yellow, round, flat faced beveled edge tablet debossed with on one side and 635 on the other side contains 40 mg of lovastatin, USP. Tablets are supplied in bottles of 60 (NDC 45963-635-01) and 500 (NDC 45963-635-04).Dispense in a tight, light-resistant container as defined in the USP.Store between 5° to 25°C (41° to 77°F). Protect from light and store in a well-closed, light-resistant container.Manufactured by:Actavis Elizabeth LLCElizabeth, NJ 07207 USADistributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USA40-9186Revised – March  2017Lovastatin Tablets, USP are available as follows:10 mg — Each white, round, flat faced beveled edge tablet debossed with on one side and 633 on the other side contains 10 mg of lovastatin, USP. Tablets are supplied in bottles of 60 (NDC 45963-633-01) and 500 (NDC 45963-633-04).20 mg — Each pink, round, flat faced beveled edge tablet debossed with on one side and 634 on the other side contains 20 mg of lovastatin, USP. Tablets are supplied in bottles of 60 (NDC 45963-634-01) and 500 (NDC 45963-634-04).40 mg — Each yellow, round, flat faced beveled edge tablet debossed with on one side and 635 on the other side contains 40 mg of lovastatin, USP. Tablets are supplied in bottles of 60 (NDC 45963-635-01) and 500 (NDC 45963-635-04).Dispense in a tight, light-resistant container as defined in the USP.Store between 5° to 25°C (41° to 77°F). Protect from light and store in a well-closed, light-resistant container.Manufactured by:Actavis Elizabeth LLCElizabeth, NJ 07207 USADistributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USA40-9186Revised – March  2017Lovastatin Tablets, USP are available as follows:10 mg — Each white, round, flat faced beveled edge tablet debossed with on one side and 633 on the other side contains 10 mg of lovastatin, USP. Tablets are supplied in bottles of 60 (NDC 45963-633-01) and 500 (NDC 45963-633-04).20 mg — Each pink, round, flat faced beveled edge tablet debossed with on one side and 634 on the other side contains 20 mg of lovastatin, USP. Tablets are supplied in bottles of 60 (NDC 45963-634-01) and 500 (NDC 45963-634-04).40 mg — Each yellow, round, flat faced beveled edge tablet debossed with on one side and 635 on the other side contains 40 mg of lovastatin, USP. Tablets are supplied in bottles of 60 (NDC 45963-635-01) and 500 (NDC 45963-635-04).Dispense in a tight, light-resistant container as defined in the USP.Store between 5° to 25°C (41° to 77°F). Protect from light and store in a well-closed, light-resistant container.Manufactured by:Actavis Elizabeth LLCElizabeth, NJ 07207 USADistributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USA40-9186Revised – March  2017Lovastatin Tablets, USP are available as follows:10 mg — Each white, round, flat faced beveled edge tablet debossed with on one side and 633 on the other side contains 10 mg of lovastatin, USP. Tablets are supplied in bottles of 60 (NDC 45963-633-01) and 500 (NDC 45963-633-04).20 mg — Each pink, round, flat faced beveled edge tablet debossed with on one side and 634 on the other side contains 20 mg of lovastatin, USP. Tablets are supplied in bottles of 60 (NDC 45963-634-01) and 500 (NDC 45963-634-04).40 mg — Each yellow, round, flat faced beveled edge tablet debossed with on one side and 635 on the other side contains 40 mg of lovastatin, USP. Tablets are supplied in bottles of 60 (NDC 45963-635-01) and 500 (NDC 45963-635-04).Dispense in a tight, light-resistant container as defined in the USP.Store between 5° to 25°C (41° to 77°F). Protect from light and store in a well-closed, light-resistant container.Manufactured by:Actavis Elizabeth LLCElizabeth, NJ 07207 USADistributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USA40-9186Revised – March  2017Lovastatin Tablets, USP are available as follows:10 mg — Each white, round, flat faced beveled edge tablet debossed with on one side and 633 on the other side contains 10 mg of lovastatin, USP. Tablets are supplied in bottles of 60 (NDC 45963-633-01) and 500 (NDC 45963-633-04).20 mg — Each pink, round, flat faced beveled edge tablet debossed with on one side and 634 on the other side contains 20 mg of lovastatin, USP. Tablets are supplied in bottles of 60 (NDC 45963-634-01) and 500 (NDC 45963-634-04).40 mg — Each yellow, round, flat faced beveled edge tablet debossed with on one side and 635 on the other side contains 40 mg of lovastatin, USP. Tablets are supplied in bottles of 60 (NDC 45963-635-01) and 500 (NDC 45963-635-04).Dispense in a tight, light-resistant container as defined in the USP.Store between 5° to 25°C (41° to 77°F). Protect from light and store in a well-closed, light-resistant container.Manufactured by:Actavis Elizabeth LLCElizabeth, NJ 07207 USADistributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USA40-9186Revised – March  2017Lovastatin Tablets, USP are available as follows:10 mg — Each white, round, flat faced beveled edge tablet debossed with on one side and 633 on the other side contains 10 mg of lovastatin, USP. Tablets are supplied in bottles of 60 (NDC 45963-633-01) and 500 (NDC 45963-633-04).20 mg — Each pink, round, flat faced beveled edge tablet debossed with on one side and 634 on the other side contains 20 mg of lovastatin, USP. Tablets are supplied in bottles of 60 (NDC 45963-634-01) and 500 (NDC 45963-634-04).40 mg — Each yellow, round, flat faced beveled edge tablet debossed with on one side and 635 on the other side contains 40 mg of lovastatin, USP. Tablets are supplied in bottles of 60 (NDC 45963-635-01) and 500 (NDC 45963-635-04).Dispense in a tight, light-resistant container as defined in the USP.Store between 5° to 25°C (41° to 77°F). Protect from light and store in a well-closed, light-resistant container.Manufactured by:Actavis Elizabeth LLCElizabeth, NJ 07207 USADistributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USA40-9186Revised – March  2017Lovastatin Tablets, USP are available as follows:10 mg — Each white, round, flat faced beveled edge tablet debossed with on one side and 633 on the other side contains 10 mg of lovastatin, USP. Tablets are supplied in bottles of 60 (NDC 45963-633-01) and 500 (NDC 45963-633-04).20 mg — Each pink, round, flat faced beveled edge tablet debossed with on one side and 634 on the other side contains 20 mg of lovastatin, USP. Tablets are supplied in bottles of 60 (NDC 45963-634-01) and 500 (NDC 45963-634-04).40 mg — Each yellow, round, flat faced beveled edge tablet debossed with on one side and 635 on the other side contains 40 mg of lovastatin, USP. Tablets are supplied in bottles of 60 (NDC 45963-635-01) and 500 (NDC 45963-635-04).Dispense in a tight, light-resistant container as defined in the USP.Store between 5° to 25°C (41° to 77°F). Protect from light and store in a well-closed, light-resistant container.Manufactured by:Actavis Elizabeth LLCElizabeth, NJ 07207 USADistributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USA40-9186Revised – March  2017


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Brodalumab is a human monoclonal IgG2 antibody that selectively binds to human IL-17RA and inhibits its interactions with cytokines IL-17A, IL-17F, IL-17C, IL-17A/F heterodimer and IL-25. IL-17RA is a protein expressed on the cell surface and is a required component of receptor complexes utilized by multiple IL-17 family cytokines. Blocking IL-17RA inhibits IL-17 cytokine-induced responses including the release of pro-inflammatory cytokines and chemokines.

Non-Clinical Toxicology
SILIQ is contraindicated in patients with Crohn’s disease because SILIQ may cause worsening of disease

CYP3A4 Interactions













Danazol, Diltiazem, Dronedarone or Verapamil:

Amiodarone:

Coumarin Anticoagulants:

Colchicine:

Ranolazine:

Propranolol:

Digoxin:

Oral Hypoglycemic Agents:

Endocrine Function

HMG-CoA reductase inhibitors interfere with cholesterol synthesis and as such might theoretically blunt adrenal and/or gonadal steroid production. Results of clinical trials with drugs in this class have been inconsistent with regard to drug effects on basal and reserve steroid levels. However, clinical studies have shown that lovastatin does not reduce basal plasma cortisol concentration or impair adrenal reserve, and does not reduce basal plasma testosterone concentration. Another HMG-CoA reductase inhibitor has been shown to reduce the plasma testosterone response to HCG. In the same study, the mean testosterone response to HCG was slightly but not significantly reduced after treatment with lovastatin 40 mg daily for 16 weeks in 21 men. The effects of HMG-CoA reductase inhibitors on male fertility have not been studied in adequate numbers of male patients. The effects, if any, on the pituitary-gonadal axis in pre-menopausal women are unknown. Patients treated with lovastatin who develop clinical evidence of endocrine dysfunction should be evaluated appropriately. Caution should also be exercised if an HMG-CoA reductase inhibitor or other agent used to lower cholesterol levels is administered to patients also receiving other drugs (e.g., spironolactone, cimetidine) that may decrease the levels or activity of endogenous steroid hormones.

CNS Toxicity

CNS vascular lesions, characterized by perivascular hemorrhage and edema, mononuclear cell infiltration of perivascular spaces, perivascular fibrin deposits and necrosis of small vessels, were seen in dogs treated with lovastatin at a dose of 180 mg/kg/day, a dose which produced plasma drug levels (C) which were about 30 times higher than the mean values in humans taking 80 mg/day.

Similar optic nerve and CNS vascular lesions have been observed with other drugs of this class.

Cataracts were seen in dogs treated for 11 and 28 weeks at 180 mg/kg/day and 1 year at 60 mg/kg/day.

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 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

The following serious adverse reactions are discussed in greater detail in other sections of labeling:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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