| 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
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.
RECOMMENDED DOSING
Dosing for Your Adult Crohn’s Disease and Ulcerative Colitis Patients
For new patients, induction with appropriate dosing is critical in order to achieve disease control and induce remission*.
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.
Administration Considerations1
- Prior to initiating HUMIRA and periodically during therapy, patients should be evaluated for active tuberculosis and tested for latent infection.
- In placebo-controlled trials, the most common adverse reaction was injection site reactions (20% with HUMIRA vs 14% with placebo). Most were mild and did not necessitate discontinuation.
- Anaphylaxis or serious allergic reaction may occur.
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.
HUMIRA CITRATE-FREE
HUMIRA Citrate-free provides less pain immediately following injection vs the original presentation of HUMIRA2,*
The same HUMIRA efficacy and safety profile you and your patients have come to count on
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
Have you asked all your existing HUMIRA patients about their injection experience?
Have you asked all your existing HUMIRA patients about their injection experience?
Don’t wait until their prescription is up for renewal
- Many patients may not be telling you about the pain they experience
- It might be an important factor impacting a patient’s commitment to their long-term treatment routine
*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.
HUMIRA Citrate-free Resources
EMR=electronic medical record
TRANSITION TO HUMIRA CITRATE-FREE
How do I transition my patients to HUMIRA Citrate-free?
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
What to tell your patients who are transitioning from the original presentation
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,*
- Although the injection may feel different, they should continue to follow proper injection technique
- Patients should confirm the injection is complete before removing the Pen or syringe
- Mention that the packaging will look different
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.
INDICATIONS1
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.
IMPORTANT SAFETY INFORMATION1
SERIOUS INFECTIONS
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:
- Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Test patients for latent TB before HUMIRA use and during therapy. Initiate treatment for latent TB prior to HUMIRA use.
- Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. 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. Consider empiric anti‑fungal therapy 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.
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.
- Do not start HUMIRA during an active infection, including localized infections.
- Patients older than 65 years, patients with co‑morbid conditions, and/or patients taking concomitant immunosuppressants may be at greater risk of infection.
- If an infection develops, monitor carefully and initiate appropriate therapy.
- Drug interactions with biologic products: A higher rate of serious infections has been observed in RA patients treated with rituximab who received subsequent treatment with a TNF blocker. An increased risk of serious infections has been seen with the combination of TNF blockers with anakinra or abatacept, with no demonstrated added benefit in patients with RA. Concomitant administration of HUMIRA with other biologic DMARDs (e.g., anakinra or abatacept) or other TNF blockers is not recommended based on the possible increased risk for infections and other potential pharmacological interactions.
MALIGNANCY
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.
- Consider the risks and benefits of HUMIRA treatment prior to initiating or continuing therapy in a patient with known malignancy.
- In clinical trials, more cases of malignancies were observed among HUMIRA-treated patients compared to control patients.
- Non‑melanoma skin cancer (NMSC) was reported during clinical trials for HUMIRA‑treated patients. Examine all patients, particularly those with a history of prolonged immunosuppressant or PUVA therapy, for the presence of NMSC prior to and during treatment with HUMIRA.
- In HUMIRA clinical trials, there was an approximate 3‑fold higher rate of lymphoma than expected in the general U.S. population. Patients with chronic inflammatory diseases, particularly those with highly active disease and/or chronic exposure to immunosuppressant therapies, may be at higher risk of lymphoma than the general population, even in the absence of TNF blockers.
- Postmarketing cases of acute and chronic leukemia were reported with TNF blocker use. Approximately half of the postmarketing cases of malignancies in children, adolescents, and young adults receiving TNF blockers were lymphomas; other cases included rare malignancies associated with immunosuppression and malignancies not usually observed in children and adolescents.
HYPERSENSITIVITY
- Anaphylaxis and angioneurotic edema have been reported following HUMIRA administration. If a serious allergic reaction occurs, stop HUMIRA and institute appropriate therapy.
HEPATITIS B VIRUS REACTIVATION
- Use of TNF blockers, including HUMIRA, may increase the risk of reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. Some cases have been fatal.
- Evaluate patients at risk for HBV infection for prior evidence of HBV infection before initiating TNF blocker therapy.
- Exercise caution in patients who are carriers of HBV and monitor them during and after HUMIRA treatment.
- Discontinue HUMIRA and begin antiviral therapy in patients who develop HBV reactivation. Exercise caution when resuming HUMIRA after HBV treatment.
NEUROLOGIC REACTIONS
- TNF blockers, including HUMIRA, have been associated with rare cases of new onset or exacerbation of central nervous system and peripheral demyelinating diseases, including multiple sclerosis, optic neuritis, and Guillain‑Barré syndrome.
- Exercise caution when considering HUMIRA for patients with these disorders; discontinuation of HUMIRA should be considered if any of these disorders develop.
- There is a known association between intermediate uveitis and central demyelinating disorders.
HEMATOLOGIC REACTIONS
- Rare reports of pancytopenia, including aplastic anemia, have been reported with TNF blockers. Medically significant cytopenia has been infrequently reported with HUMIRA.
- Consider stopping HUMIRA if significant hematologic abnormalities occur.
CONGESTIVE HEART FAILURE
- Worsening and new onset congestive heart failure (CHF) has been reported with TNF blockers. Cases of worsening CHF have been observed with HUMIRA; exercise caution and monitor carefully.
AUTOIMMUNITY
- Treatment with HUMIRA may result in the formation of autoantibodies and, rarely, in development of a lupus‑like syndrome. Discontinue treatment if symptoms of a lupus‑like syndrome develop.
IMMUNIZATIONS
- Patients on HUMIRA should not receive live vaccines.
- Pediatric patients, if possible, should be brought up to date with all immunizations before initiating HUMIRA therapy.
- Adalimumab is actively transferred across the placenta during the third trimester of pregnancy and may affect immune response in the in utero exposed infant. The safety of administering live or live‑attenuated vaccines in infants exposed to HUMIRA in utero is unknown. Risks and benefits should be considered prior to vaccinating (live or live‑attenuated) exposed infants.
ADVERSE REACTIONS
- The most common adverse reactions in HUMIRA clinical trials (>10%) were: infections (e.g., upper respiratory, sinusitis), injection site reactions, headache, and rash.
INDICATIONS1
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.
Select Prespecified Endpoints
Statistical Considerations:
- The statistical analyses for the endpoints in both ULTRA 1 and ULTRA 2 were carried out in hierarchical order from the first to the second ranked co‑primary endpoints, and then to the ranked secondary endpoints. If a higher ranked endpoint did not meet the criteria for statistical significance (P value <0.05), then the analyses of the remaining ranked endpoints would be considered exploratory
- For ULTRA 1, the co-primary endpoint of clinical remission at Week 8 for the 80/40/40 mg dosing arm did not achieve statistical significance. As a result, the analyses of the ranked secondary endpoints are considered exploratory
- For ULTRA 2, results of ranked secondary endpoints that were considered exploratory are not presented in the chart
NS=not statistically significant
aAreas in the table that contain a hyphen (-) indicate endpoints that were not prespecified.
bClinical response is defined as a decrease in full Mayo score of ≥3 points from baseline and a decrease in full Mayo score of ≥30% from baseline and a decrease in the rectal bleeding score of ≥1 or an absolute rectal bleeding score of 0 or 1.
cMucosal healing is defined as an endoscopy subscore of 0 or 1 and did not include a histological analysis.
dRestricted to patients using corticosteroids at baseline (control, n=140; HUMIRA, n=150).
US-HUMG-190451
GAIN Study1,3
Remission* at Week 4 (Primary Endpoint)1,3
Response† at Week 4 (Secondary Endpoint)1,3
Study Design Intro: 4‑week, randomized, double‑blind, placebo‑controlled study in 325 adults with moderately to severely active Crohn’s disease who lost response to, or intolerant to, infliximab. Patients were randomized to receive HUMIRA or control (placebo), both ± concomitant conventional therapy. Primary endpoint: percentage of patients achieving induction of clinical remission at Week 4.1,3
aP<0.001, HUMIRA vs control.
bP<0.01, HUMIRA vs control.
*Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) score <150 points.
†Clinical response (CR-70; symptom improvement) was defined as a reduction of ≥70 points from baseline CDAI score.
GAIN Study Design1,3
Duration: 4‑week, randomized, double‑blind, placebo‑controlled, multicenter study
Patients: 325 adults with moderately to severely active Crohn's disease (defined by a Crohn’s Disease Activity Index (CDAI) score of 220–450 points) who lost response to, or were intolerant to, infliximab
Concomitant Therapies: All patients may have received concomitant stable doses of conventional therapies that included 5‑aminosalicylates, immunomodulators, corticosteroids, and Crohn's‑related antibiotics
Dosing: Patients were randomized to receive 160 mg at Week 0 and 80 mg at Week 2, or control (placebo), both ± concomitant therapy and followed through Week 4
Primary Endpoint: Percentage of patients achieving induction of clinical remission* in HUMIRA‑treated patients vs control at Week 4
Secondary Endpoint: Percentage of patients achieving clinical response† (CR‑70) at Week 4
*Clinical remission was defined as a CDAI score <150 points.
†Clinical response (CR‑70; symptom improvement) was defined as a reduction of ≥70 points from baseline CDAI score.
US-HUMG-190451