Charles Crutchfield

Biologic Medication Information

(for commonly used dermatologic biologic medications)

Medication: Dosing: Device Type: Lab Work: Indication: Contraindication: Immunization: Mechanism of action: Black box warning:
Enbrel 50mg (etanercept) Initial: Inject 50mg SQ twice weekly x 3 months on the same day.
Maint: Starting month 4, then inject 50mg SQ once weekly on the same day.
Sureclick (Pen), Pre-filled syringe or Vial TB (Mantoux) prior and every year while on Enbrel Psoriasis and Psoriatic Arthritis

Use of Enbrel with Anakinra or Abatacept is not recommended these are both immunosuppressant drugs.


Congestive Heart failure, Lupus and Multiple Sclerosis

Use of Enbrel with Anakinra or Abatacept is not recommended these are both immunosuppressant drugs. Etanercept is adimeric soluble form of the p75 TNF receptor that can bind TNF molecules. Etanercept inhibits binding of TNF-alpha and TNF-beta (lymphotoxin alpha [LT-alpha]) to cell surface TNFRs, rendering TNF biologically inactive. Serious Infections and Malignancies (see package insert for complete details)
Enbrel 25mg (etanercept)
PEDIATRIC DOSING (4-7 years old) (etanercept)

*Recommended weekly dose 0.8mg/kg up to a maximum dose of 50mg every week.

-0.8mg/kg (0.36mg/lb) for pediatric patients who weight <138lb (63kg)

-50mg for pediatric patients who weight >135 lbs (63kg)

Convert pounds to Kilograms for accurate dosing

Ex: lbs x 0.4536= kg

Less than 68lb (25mg)

68lb to <138lbs: (25mg)

>138lbs: (25mg, 50mg)

Multiple-Use Vial, Prefilled Syringe And SureClick Autoinjector TB (Mantoux) prior and every year while on Enbrel Chronic Moderate to severe Plaque Psoriasis The use of Enbrel in patient's receiving concurrent cyclophosphamide therapy is not recommended. The risk of serious infection may increase with concomitant us if abatacept. Concurrent therapy with Enbrel and anakinra is not recommended. Hypoglycemia has been reported followings initiation of Enbrel therapy in patients receiving medications fir diabetes, necessitating a reduction in anti-diabetes in some pt. Use of Enbrel with Anakinra or Abatacept is not recommended these are both immunosuppressant drugs Etanercept is adimeric soluble form of the p75 TNF receptor that can bind TNF molecules. Etanercept inhibits binding of TNF-alpha and TNF-beta (lymphotoxin alpha [LT-alpha]) to cell surface TNFRs, rendering TNF biologically inactive. Serious infections and Malignancy (see full prescribing for complete boxed warning)
Humira 40mg/0.8ml (adalimumab) Initial: Inject 80mg (2pens) SQ on Day 1, then inject 40mg (1pen) SQ on Day 8,
Maint: Then Inject 40mg SQ every other week on the same day.
Auto-injector (pen), or Prefilled syringe TB (mantoux) prior to starting and every year while on Humira Psoriasis and Psoriatic Arthritis Congestive Heart failure, Lupus and Multiple Sclerosis No live vaccines, Make sure pt is up-to-date on all immunizations prior to starting Humira Adalimumab binds specifically to TNF-alpha and blocks its interaction with the p55 and p75 cell surface TNF receptors Serious infections and Malignancy (see full prescribing for complete boxed warning)
Humira 40mg/0.8ml (adalimumab) Initial: Inject 160mg (4 pens) SQ on day 1, then inject 80mg (2pens) SQ on Day 15,
Maint: Day 29 Inject 40mg SQ once weekly on the same day and thereafter.
Auto-injector (pen), or Prefilled syringe TB (mantoux) prior to starting and every year while on Humira Hidradenitis Suppurativa Congestive Heart failure, Lupus and Multiple Sclerosis No live vaccines, Make sure pt is up-to-date on all immunizations prior to starting Humira Adalimumab binds specifically to TNF-alpha and blocks its interaction with the p55 and p75 cell surface TNF receptors Serious infections and Malignancy (see full prescribing for complete boxed warning)
Stelara 45mg (ustekinumab) (Less than 200 lbs)
Initial: Inject 45mg SQ on Day 0, and then inject 45mg SQ on Day 28.
Maint: then inject 45 mg once every 12 weeks.
Prefilled Syringe TB (mantoux) prior to starting and every year while on Stelara and BCG vaccines should not be given during treatment with Stelara or for one year following d/c. Psoriasis and Psoriatic Arthritis Clinically significant hypersensitivity to Stelara or to any of the excipients. No live vaccines make sure pt is up-to-date on immunizations prior to starting Stelara. Ustekinumab is a human IgG1κ monoclonal antibody that binds with specificity to the p40 protein subunit used by both the IL-12 and IL-23 cytokines. IL-12 and IL-23 are naturally occurring cytokines that are involved in inflammatory and immune responses, such as natural killer cell activation and CD4+ T-cell differentiation and activation. In in vitro models, ustekinumab was shown to disrupt IL-12 and IL-23 mediated signaling and cytokine cascades by disrupting the interaction of these cytokines with a shared cell-surface receptor chain, IL-12Rbeta1. None
Stelara 90mg (ustekinumab) (Over 200lbs) Initial: Inject 90mg SQ on Day 0, And then inject 90mg SQ on Day 28.
Maint: then inject 90mg once every 12 weeks.
Prefilled Syringe TB (mantoux) prior to starting and every year while on Stelara and BCG vaccines should not be given during treatment with Stelara or for one year following d/c. Psoriasis and Psoriatic Arthritis Clinically significant hypersensitivity to Stelara or to any of the excipients. No live vaccines make sure pt is up-to-date on immunizations prior to starting Stelara. See above information None
Cosentyx (secukinumab) Initial: Inject 300mg (2pens) SQ weekly on week 0, 1, 2, 3, 4.
Maint: Inject 300mg (2pens) once every 4 weeks.
Sensoready Pen (Auto-injector) or Prefilled Syringe TB (Mantoux) prior starting and ever year while on Cosentyx Psoriasis and Psoriatic Arthritis Patient is allergic to Cosentyx. No live vaccines Make sure pt is up-to-date on all immunizations prior to starting Cosentyx. Secukinumab is a human IgG1 monoclonal antibody that selectively binds to the interleukin- 17A(IL17A)cytokine and Inhibits its interaction with the IL-17 receptor. None
Taltz 80mg (ixekizumab) Initial: Inject 160mg (2pens) SQ on Day 0, 1st 12weeks: then Inject 80mg (1pen) SQ every 2 weeks x 12 weeks on the same day,
Maint: After 12 weeks: Then Inject 80 mg SQ every 4 weeks on the same day.
Auto-injector and Prefilled Syringes TB (Mantoux) prior to starting and every year while on Taltz Psoriasis and Psoriatic Arthritis Serious hypersensitivity reaction to Taltz or to any excipients. No Live Vaccines make sure pt is up-to-date on all vaccines before starting Taltz Ixekizumab is 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 None

Otezla (apremilast)

Otezla (apremilast) is not a biologic agent, but we are including it in the chart because it is FDA approved treat psoriasis in situations where a biologic may be considered, and for reader convenience

Starter Pak: Take as directed (Given in office).
Maintenance: Take 30mg twice daily. (12 hours apart)
Tablets No lab work needed Psoriasis and Psoriatic Arthritis Hypersensitivity to Apremilast or to any excipients in the formulation The effect of apremilast on vaccine-mediated immune responses has not been clinically assessed. Apremilast is an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) specific for cyclic adenosine monophosphate (cAMP) PDE4 inhibition results in increased intracellular cAMP levels. None
Remicade (INFLIXMAB) Initial Dose: 5 mg/kg given as an intravenous induction regimen at 0, 2 and 6 weeks. Maintenance: regimen of 5 mg/kg every 8 weeks thereafter for the treatment of chronic severe (i.e., extensive and/or disabling) plaque psoriasis. IV infusion TB (Mantoux) prior starting and yearly Plaque Psoriasis and Psoriatic Arthritis REMICADE at doses >5 mg/kg should not be administered to patients with moderate to severe heart failure. In a randomized study evaluating REMICADE in patients with moderate to severe heart failure (New York Heart Association REMICADE ® (infliximab) REMICADE ® (infliximab) 4 [NYHA] Functional Class III/IV), REMICADE treatment at 10 mg/kg was associated with an increased incidence of death and hospitalization due to worsening heart failure [see Warnings and Precautions (5.5) and Adverse Reactions (6.1)]. REMICADE should not be re-administered to patients who have experienced a severe hypersensitivity reaction to REMICADE. Additionally, REMICADE should not be administered to patients with known hypersensitivity to inactive components of the product or to any murine proteins. No live vaccines Infliximab neutralizes the biological activity of TNF-alpha by binding with high affinity to the soluble and transmembrane forms of TNF-alpha and inhibits binding of TNF-alpha with its receptors. Infliximab does not neutralize TNF-beta (lymphotoxin-alpha), a related cytokine that utilizes the same receptors as TNF-alpha. Biological activities attributed to TNF-alpha include: induction of pro-inflammatory cytokines such as interleukins (IL) 1 and 6, enhancement of leukocyte migration by increasing endothelial layer permeability and expression of adhesion molecules by endothelial cells and leukocytes, activation of neutrophil and eosinophil functional activity, induction of acute phase reactants and other liver proteins, as well as tissue degrading enzymes produced by synoviocytes and/or chondrocytes. Cells expressing transmembrane TNF-alpha bound by infliximab can be lysed in vitro or in vivo. Infliximab inhibits the functional activity of TNF-alpha in a wide variety of in vitro bioassays utilizing human fibroblasts, endothelial cells, neutrophils, B and T-lymphocytes and epithelial cells. The relationship of these biological response markers to the mechanism(s) by which REMICADE exerts its clinical effects is unknown. Anti-TNF-alpha antibodies reduce disease activity in the cotton-top tamarin colitis model, and decrease synovitis and joint erosions in a murine model of collagen-induced arthritis. Infliximab prevents disease in transgenic mice that develop polyarthritis as a result of constitutive expression of human TNF-alpha, and when administered after disease onset, allows eroded joints to heal. Serious Infections and Malignancies (see package insert for complete details)
Xolair (Omalizumab)

Asthma: Xolair 75 to 375mg SC every 2 or 4 weeks. -Determine dose (mg) and dosing frequency by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg)

Urticaria: Xolair 150 or 300mg SC every 4 weeks. Dosing in CIU is not dependent on serum IgE level or body weight.

Vial In asthma patients, a blood test for a substance called IgE must be performed prior to starting XOLAIR to determine the appropriate dose and dosing frequency. No labs needed for patient with chronic idiopathic Urticaria Moderate to severe persistent asthma in patients 6 years of age and older or Chronic Idiopathic Urticaria. Patients who are allergic to omalizumab or any of the ingredients.

Have any other allergies (such as food allergy or seasonal allergies)

Have sudden breathing problems (bronchospasm)

Have ever had a severe allergic reaction called anaphylaxis

Have or have had a parasitic infection

Cancer are pregnant or plan to become pregnant.

Breastfeeding or plan to breastfeed.

Asthma Omalizumab inhibits the binding of IgE to the high-affinity IgE receptor (Fc small letter epsilon RI) on the surface of mast cells and basophils. Reduction in surface-bound IgE on Fc small letter epsilon RI -bearing cells limits the degree of release of mediators of the allergic response. Treatment with Xolair also reduces the number of Fc small letter epsilon RI receptors on basophils in atopic patients. Chronic Idiopathic Urticaria Omalizumab binds to IgE and lowers free IgE levels. Subsequently, IgE receptors (Fc small letter epsilon RI) on cells down -regulate. The mechanism by which these effects of omalizumab NAPHYLAXIS See full prescribing information for complete boxed warning.Anaphylaxis, presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue, has been reported to occur after administration of Xolair. Anaphylaxis has occurred after the first dose of Xolair but also has occurred beyond 1year after beginning treatment. Closely observe patients for an appropriate period of time after Xolair administration and be prepared to manage anaphylaxis that can be life-threatening. Inform patients of the signs and symptoms of anaphylaxis and have them seek immediate medical care should symptoms occur. (5.1)
TREMFYA (guselkumab)

Inject 100 mg/ml Subcutaneously at week 0 and week 4. Then inject 100mg every 8 weeks thereafter.

Prefilled Syringe TB (mantoux) prior to starting therapy and yearly Adult patient with moderate-severe plaque Psoriasis NONE

Avoid live vaccines and all age appropriate immunizations according to current immunization guidelines.

Guselkumab is a human monoclonal IgG1λ antibody that selectively binds to the p19 subunit of interleukin 23 (IL-23) and inhibits its interaction with the IL-23 receptor. IL-23 is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. Guselkumab inhibits the release of proinflammatory cytokines and chemokines. NONE
SILIQ (brodalumab)

Inject 210mg Sub Q at week 0, 1, 2.

Then inject 210mg Sub Q every 2 weeks.

Prefilled Syringe TB (mantoux) prior to starting and yearly Moderate to severe plaque Psoriasis in Adults Crohn's disease

Avoid live vaccines.

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. WARNING: SUICIDAL IDEATION AND BEHAVIOR See full prescribing information for complete boxed warning. ⚫ Suicidal ideation and behavior, including completed suicides, have occurred in patients treated with SILIQ. (5.1, 6.1) ⚫ Prior to prescribing, weigh potential risks and benefits in patients with a history of depression and/or suicidal ideation or behavior. (5.1) ⚫ Patients with new or worsening suicidal thoughts and behavior should be referred to a mental health professional, as appropriate. (5.1) ⚫ Advise patients and caregivers to seek medical attention for manifestations of suicidal ideation or behavior, new onset or worsening depression, anxiety, or other mood changes. (5.1) ⚫ SILIQ is available only through a restricted program called the SILIQ REMS Program. (5.2)
ILUMYA (tildrakizumab-asmn)

Inject 100mg at week 0,4 and every 12 weeks thereafter

Prefilled Syringe TB prior to starting and yearly Moderate to severe plaque Psoriasis Ilumya is contraindications with patients with previous serious hypersensitivity reaction to tildarakizumab

No live vaccines

Tildrakizumab us a humanized IgG/k monoclonal antibody that selectively binds to the p 19 subunit IL-23 and inhibits its interaction with IL-23 receptor. IL-23 is a naturally occurring cytokine that is involved in inflammatory and immune response. Tildrakizumab inhibits the release of proinflammatory cytokines and chemokines. None
CIMZIA (CERTOLIZUMAB PEGOL)

Plaque Psoriasis: Inject 400 mg (given as 2 subcutaneous injections of 200 mg each) every other week. For some patients (with body weight <= 90 kg), a dose of 400 mg (given as 2 subcutaneous injections of 200 mg each) initially and at Weeks 2 and 4, followed by 200 mg every other week may be considered.

Psoriatic Arthritis: Inject 400 mg initially and at week 2 and 4, followed by 200 mg every other week; for maintenance dosing, Inject 400 mg every 4 weeks and be considered

Prefilled Syringe TB prior to started and yearly Moderate to severe plaque Psoriasis and Psoriatic Arthririts CIMZIA is contraindicated in patients with a history of hypersensitiviy reaction to certolizumab pegol or to any of the excipients. Reactions have included angioedema, anaphylactoid reaction, serum sickness, and urticaria [see Warnings and Precautions (5.4)]. Use with Anakinra, Abatacept, Rituximab, and Natalizumab

No live vaccines

Certolizumab pegol binds to human TNFα with a KD of 90pM. TNFα is a key pro -inflammatory cytokine with a central role in inflammatory processes. Certolizumab pegol selectively neutralizes TNFα (IC 90 of 4 ng/mL for inhibition of human TNFα in the in vitro L929 murine fibrosarcoma cytotoxicity assay) but does not neutralize lymphotoxin α (TNFβ). Certolizumab pegol cross-reacts poorly with TNF from rodents and rabbits, therefore in vivo efficacy was evaluated using animal models in which human TNF? was the physiologically active molecule. Certolizumab pegol was shown to neutralize membrane -associated and soluble human TNFα in a dose -dependent SERIOUS INFECTIONS Patients treated with CIMZIA are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions (5.1) and Adverse Reactions (6.1)]. Most patients who developed these infections were taking concomitant immunosuppre-ssants such as methotrexate or corticosteroids. CIMZIA should be discontinued if a patient develops a serious infection or sepsis. Reported infections include: ?Active tuberculosis, including reactivation of latent tuberculosis. Patients with tuberculosis have frequently presented with disseminated or extrapulmonay disease. Patients should be tested for latent tuberculosis before CIMZIA use and during therapy. Treatment for latent infection should be initiated prior to CIMZIA use. ?Invasive fungal infections, including histoplasmosis, coccidioidomy-cosis, candidiasis, aspergillosis, blastomycosis, and pneumocy-stosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Empiric anti -fungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness. ?Bacterial, viral and other infections due to opportunistic pathogens , including Legionella and Listeria. The risks and benefits of treatment with CIMZIA should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with CIMZIA, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy. [see Warnings and Precautions (5.1) and Adverse Reactions (6.1)]. MALIGNANY Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, of which CIMZIA is a member [see Warnings and Precautions (5.2)]. CIMZIA is not indicated for use in pediatric patients.
Dupixent (dupilimab)

Initial: Inject 600mg (2 syringes) subcutaneously on day 0. Maintenance: Inject 300mg (1 syringe subcutaneously every 2 weeks. r

Prefilled Syringe None Adult with moderate to serve Atopic Dermatitis Hypersensitivity to Dupixent (dupilimab)

No live vaccines

Dupilumab is a human monoclonal IgG4 antibody that inhibits interleukin-4 (IL-4) and interleukin-13 (IL-13) signaling by specifically binding to the IL-4Rα subunit shared by the IL-4 and IL-13 receptor complexes. Dupilumab inhibits IL-4 signaling via the Type I receptor and both IL-4 and IL-13 signaling through the Type II receptor. Blocking IL-4Rα with dupilumab inhibits IL-4 and IL-13 cytokine- induced responses, including the release of proinflammatory cytokines, chemokines and IgE. Conjunctivitis and Keratitis, Comorbid Asthma and Parasitic (Helminth) Infections (see prescribing information for more details)

Before starting check TB status, HIV status, Hepatitis panel and fungal serologies, if indicated, (e.g. participates outdoor activities with high rate of blasto/other exposure).

Many people on Cosentyx experience weight loss, be sure to monitor for weight change at visits.

IL-17 antagonists have been reported to cause a flare in patients with inflammatory bowel disease, be sure to consider this when starting a ptient on an IL-17 antagonist (Talz and Cosentyx)