New Patients | Maintenance Dose Patients | |
---|---|---|
NDC | 0074-0124-03 | 0074-0554-02 |
Packaging Configuration | 3 — 80 mg/0.8 mL Pens | 2 — 40 mg/0.4 mL Pens |
Don't wait
Transition your patients to HUMIRA Citrate‑free so that they may experience less pain immediately following injection vs the original presentation of HUMIRA.2,*
HUMIRA Citrate-free Prescribing at a Glance1
New Patients | Maintenance Dose Patients | |
---|---|---|
NDC | 0074-0124-03 | 0074-0554-02 |
Packaging Configuration | 3 — 80 mg/0.8 mL Pens | 2 — 40 mg/0.4 mL Pens |
NDC=national drug code
*Injection site pain immediately following injection as measured using a 0-10 cm Visual Analog Scale: HUMIRA 40 mg/0.4 mL vs HUMIRA 40 mg/0.8 mL.
Be sure to prescribe the HUMIRA Citrate-free induction dose, followed by the maintenance dose.1
HUMIRA Citrate-free Dose Regimen | |||
---|---|---|---|
Induction | NDC: 0074-0124-03 | ||
For NEW patients |
160 mg Day 1a |
2 80 mg/0.8 mL Pens ![]() |
|
80 mg Day 15 |
1 80 mg/0.8 mL Pen ![]() |
||
Maintenance | NDC: 0074-0554-02 | ||
For NEW and EXISTING patients |
40 mg Day 29 and every other week thereafter |
1 40 mg/0.4 mL Pen ![]() |
aAdministered as two 80 mg injections in one day or as one 80 mg injection per day for two consecutive days.
The use of HUMIRA in CD beyond 1 year has not been evaluated in controlled clinical studies.
For Adult CD Only: In a maintenance clinical trial, among patients who were not responsive by Week 12, therapy continued beyond 12 weeks did not result in significantly more responses.
For UC Only: Continue HUMIRA only in patients who have shown evidence of clinical remission by 8 weeks (Day 57) of therapy.
CD=Crohn's disease; NDC=national drug code; UC=ulcerative colitis
*Clinical remission was defined as a Crohn’s Disease Activity Index score <150 points.
All presentations of HUMIRA originate from the same master cell line1,3
The same active ingredient you have counted on for over 15 years1,3,4
*Injection site pain immediately following injection as measured using a 0-10 cm Visual Analog Scale:
HUMIRA 40 mg/0.4 mL vs HUMIRA 40 mg/0.8 mL.
*Injection site pain immediately following injection as measured using a 0-10 cm Visual Analog Scale: HUMIRA 40 mg/0.4 mL vs HUMIRA 40 mg/0.8 mL.
Meet Adam, a HUMIRA patient discussing how the transition to
HUMIRA Citrate-free has made a significant impact on his treatment experience.
EMR=electronic medical record
Prescribe HUMIRA Citrate-free for
new
and existing HUMIRA patients
Write up a new prescription for
HUMIRA Citrate-free
Include the correct NDC
to ensure your patient’s
pharmacy dispenses HUMIRA Citrate-free
The HUMIRA Citrate-free Referral and Prescription Form can be transmitted
to your patient’s preferred specialty pharmacy, and allows you to select the appropriate dosing and NDC
The form also ensures that your patients will
receive HUMIRA Citrate‑free when the form is sent
to in‑network specialty pharmacies
Reassure them that HUMIRA Citrate-free has the same efficacy and safety profile they’ve come to count on with HUMIRA, with the same active ingredient (adalimumab).1,3
Explain that they may experience less pain immediately following injection vs the original presentation.2,*
NDC=national drug code
*Injection site pain immediately following injection as measured using a 0-10 cm Visual Analog Scale: HUMIRA 40 mg/0.4 mL vs HUMIRA 40 mg/0.8 mL.
Adult Crohn’s Disease (CD): HUMIRA is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy. HUMIRA is indicated for reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab.
Ulcerative Colitis (UC): HUMIRA is indicated for inducing and sustaining clinical remission in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to immunosuppressants such as corticosteroids, azathioprine, or 6‑mercaptopurine. The effectiveness of HUMIRA has not been established in patients who have lost response to or were intolerant to anti‑TNF agents.
Patients treated with HUMIRA are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.
Discontinue HUMIRA if a patient develops a serious infection or sepsis.
Reported infections include:
Carefully consider the risks and benefits of treatment with HUMIRA prior to initiating therapy in patients: 1. with chronic or recurrent infection, 2. who have been exposed to TB, 3. with a history of opportunistic infection, 4. who resided in or traveled in regions where mycoses are endemic, 5. with underlying conditions that may predispose them to infection. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with HUMIRA, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.
Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including HUMIRA. Postmarketing cases of hepatosplenic T‑cell lymphoma (HSTCL), a rare type of T‑cell lymphoma, have been reported in patients treated with TNF blockers, including HUMIRA. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases have occurred in patients with Crohn's disease or ulcerative colitis and the majority were in adolescent and young adult males. Almost all of these patients had received treatment with azathioprine or 6‑mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. It is uncertain whether the occurrence of HSTCL is related to use of a TNF blocker or a TNF blocker in combination with these other immunosuppressants.
Rheumatoid Arthritis (RA): HUMIRA is indicated, alone or in combination with methotrexate or other non‑biologic DMARDs, for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis.
Juvenile Idiopathic Arthritis (JIA): HUMIRA is indicated, alone or in combination with methotrexate, for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older.
Psoriatic Arthritis (PsA): HUMIRA is indicated, alone or in combination with non‑biologic DMARDs, for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis.
Ankylosing Spondylitis (AS): HUMIRA is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis.
Adult Crohn's Disease (CD): HUMIRA is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy, and reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab.
Pediatric Crohn's Disease: HUMIRA is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active Crohn's disease who have had an inadequate response to corticosteroids or immunomodulators such as azathioprine, 6‑mercaptopurine, or methotrexate.
Ulcerative Colitis (UC): HUMIRA is indicated for inducing and sustaining clinical remission in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to immunosuppressants such as corticosteroids, azathioprine, or 6‑mercaptopurine. The effectiveness of HUMIRA has not been established in patients who have lost response to or were intolerant to anti‑TNF agents.
Plaque Psoriasis (Ps): HUMIRA is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. HUMIRA should only be administered to patients who will be closely monitored and have regular follow‑up visits with a physician.
Hidradenitis Suppurativa (HS): HUMIRA is indicated for the treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older.
Uveitis: HUMIRA is indicated for the treatment of non‑infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older.
Please see full Prescribing Information.
References: 1. HUMIRA Injection [package insert]. North Chicago, IL: AbbVie Inc. 2. Nash P, Vanhoof J, Hall S, et al. Randomized crossover comparison of injection site pain with 40 mg/0.4 or 0.8 mL formulations of adalimumab in patients with rheumatoid arthritis. Rheumatol Ther.
2016;3(2):257-270. 3. Tebbey PW, Varga A, Naill M, Clewell J, Venema J. Consistency of quality attributes for the glycosylated monoclonal antibody Humira® (adalimumab). MAbs. 2015;7(5):805‑811. 4. US Food and Drug Administration. HUMIRA (BLA 125057) overview. https://www.accessdata.fda.gov/scripts/cder/daf/
index.cfm?event=overview.process
&ApplNo=125057. Accessed September 03, 2019.