SEE PATIENT TYPES WHO MAY BENEFIT FROM OJJAARA

Not actual patients.
Patient Profile Frank.

MEET FRANK

A JAKi-naïve patient who has primary myelofibrosis with anemia

Patient Profile George.

MEET GEORGE

A JAKi-naïve patient who has post-PV myelofibrosis with anemia

Patient Profile Judy.

MEET JUDY

A JAKi-naïve patient who has post-ET myelofibrosis with anemia

Patient Profile Gloria.

MEET GLORIA

A JAKi-experienced patient who has primary myelofibrosis with anemia

These profiles represent hypothetical patients.

An older white male wearing a sweater over a blue checkered shirt and a brown hat.

Meet Frank, Age 76

About Frank’s case:

 

  • Frank sought an examination due to a distended abdomen, where he was diagnosed with primary myelofibrosis
  • His spleen did not cause discomfort or other symptoms at the time, and his healthcare provider decided to continue monitoring
  • At his latest examination, Frank details new fatigue, night sweats, and bone pain. His most recent CBC panel found that he now has anemia
  • As Frank is ineligible for a transplant, his provider is now considering JAK inhibitor therapy to manage his myelofibrosis with anemia and worsening symptoms

 

Not an actual patient.

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About Frank’s life:

Frank, a proud U.S. veteran, found fulfillment after his military service as a high school teacher and coach. Now retired, he enjoys peaceful days with his spouse at their lakeside home. Once an avid walker, Frank now finds his strolls by the lake to be more challenging than before.

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Treatment

  • Initial treatment: Referral to specialist
  • Comorbidities: Hyperlipidemia
  • Current diagnosis: Intermediate-risk primary MF with anemia
  • Current treatment: N/A
  • BMI: 24.5
  • Anemia status: Moderate
  • Spleen size: 5 cm below LCM
  • Transplant eligible: Not eligible
  • DIPSS* score: 4 (Intermediate-2: >65 years; Hb <10 g/dL; constitutional symptoms)

*In the DIPSS prognostic model, constitutional symptoms include weight loss, fever, and night sweats.1

Have you explored the efficacy and safety data for patients like Frank?

An older black male wearing a gray quarter zip sweater with a white shirt underneath.

Meet George, Age 68

About George’s case:
 

  • George had a myocardial infarction at age 51, which prompted him to adopt a healthier and more active lifestyle out of concern for his cardiovascular health. Four years later, at age 55, he was diagnosed with polycythemia vera
  • Three months ago, George started to notice fatigue, joint pain, and painful abdominal distension, and told his doctor about his new symptoms
  • After George’s regular CBC panel showed higher WBCs and lower hemoglobin, his hematologist-oncologist performed a bone marrow biopsy, which confirmed his secondary myelofibrosis diagnosis
  • Recently, his splenomegaly, fatigue, and symptoms have worsened. A follow-up CBC panel indicates further progression of his anemia
  • George’s doctor is considering JAK inhibitor therapy to help manage his splenomegaly and symptomatic myelofibrosis with anemia

 

Not an actual patient.

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About George’s life:

George, a software engineer, used to unwind by spending time in the outdoors. These days he’s become an armchair traveler, reading about places that he’d rather be able to explore himself.

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Treatment

  • Initial treatment: N/A
  • Comorbidities: Hypertension, history of myocardial infarction
  • Current diagnosis: Post-PV secondary MF with moderate anemia
  • Current treatment: To be determined
  • BMI: 26.7
  • Anemia status: Moderate
  • Spleen size: 8 cm below LCM
  • Transplant eligible: Not eligible
  • DIPSS* score: 3 (Intermediate-2: >65 years; Hb <10 g/dL)

*In the DIPSS prognostic model, constitutional symptoms include weight loss, fever, and night sweats.1

Would you consider starting OJJAARA in a patient like George?

An older woman with gray hair wearing a blue collared shirt and an apron.

Meet Judy, Age 71

About Judy’s case:

 

  • At 62, Judy was diagnosed with ET and treated with standard-of-care therapies
  • Two years ago, she developed post-ET myelofibrosis with moderate anemia and was started on ESA. Despite treatment, she developed symptoms and her anemia was persistent
  • Her latest examination confirms splenomegaly, worsening anemia, and continuing constitutional symptoms
  • Judy’s doctor is now considering JAK inhibitor therapy to help manage her splenomegaly and symptomatic myelofibrosis with anemia

 

Not an actual patient.

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About Judy’s life:

Judy, a retired librarian and lifelong book lover, used to organize community reading programs and bake sales at her local library. However, as her disease continues to progress, she finds herself more of an attendee than an organizer.

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Treatment

  • Initial treatment: Standard-of-care therapies
  • Comorbidities: Type 2 diabetes
  • Current diagnosis: Secondary MF (post-ET) with moderate anemia
  • Current treatment: Corticosteroids and ESA
  • BMI: 22.0
  • Anemia status: Moderate
  • Spleen size: 16 cm below LCM
  • Transplant eligible: Not eligible
  • DIPSS* score: 4 (Intermediate-2: >65 years; Hb <10 g/dL; constitutional symptoms)

*In the DIPSS prognostic model, constitutional symptoms include weight loss, fever, and night sweats.1

See how OJJAARA may help treat a patient with myelofibrosis with anemia like Judy.

An older white woman wearing a bucket style hat and a denim shirt.

Meet Gloria, Age 73

About Gloria’s case:

 

  • Eighteen months ago, Gloria was diagnosed with primary myelofibrosis and was started on JAK inhibitor therapy to address her splenomegaly
  • At a follow-up appointment, Gloria mentioned worsening fatigue and dyspnea on exertion. A CBC panel revealed she was moderately anemic with mild thrombocytopenia
  • Her doctor decided to reduce the JAK inhibitor therapy dose and started her on ESA
  • After 2 months of treatment, Gloria’s splenomegaly worsened, and her anemia remained unchanged
  • Gloria’s doctor is looking at alternate treatment options to help address her worsening symptomatic myelofibrosis with anemia

 

Not an actual patient.

Rainbow icon.

About Gloria’s life:

Gloria, a retired nurse in Florida, enjoys gardening and sharing birdwatching tips with her grandchildren. She once loved traveling to spot Florida’s diverse birdlife but now stays closer to home due to her symptoms.

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Treatment

  • Initial treatment: Ruxolitinib
  • Comorbidities: N/A
  • Current diagnosis: High-risk primary MF with moderate anemia
  • Current treatment: Reduced-dose ruxolitinib, ESA
  • BMI: 20
  • Anemia status: Moderate
  • Spleen size: 6 cm below LCM
  • Transplant eligible: Not eligible
  • DIPSS* score: 5 (High: >65 years; Hb <10 g/dL; WBC >25; circulating blasts ≥1%)

*In the DIPSS prognostic model, constitutional symptoms include weight loss, fever, and night sweats.1
BMI=body mass index; CBC=complete blood count; DIPSS=Dynamic International Prognostic Scoring System; ESA=erythropoiesis-stimulating agent; ET=essential thrombocythemia; Hb=hemoglobin; JAK=Janus kinase; JAKi=Janus kinase inhibitor; LCM=left costal margin; PV=polycythemia vera; WBC=white blood count.

Would you consider OJJAARA as a treatment option for a patient with myelofibrosis with anemia like Gloria?

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Help your patients get started on OJJAARA

Find dosing information, including recommended dosage, dosage modifications for hepatic impairments and adverse reactions, and more.

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Head-to-head clinical trials

See how OJJAARA performed in JAKi-naïve and JAKi-experienced patients who have myelofibrosis with anemia

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Well-characterized safety profile

Explore the safety profile of OJJAARA in JAKi-naïve and JAKi-experienced patients

INDICATION AND IMPORTANT SAFETY INFORMATION

INDICATION

IMPORTANT SAFETY INFORMATION

INDICATION

OJJAARA is indicated for the treatment of intermediate or high-risk myelofibrosis (MF), including primary MF or secondary MF [post-polycythemia vera (PV) and post-essential thrombocythemia (ET)], in adults with anemia.

IMPORTANT SAFETY INFORMATION

Risk of Infections

  • Serious (including fatal) infections (e.g., bacterial and viral, including COVID-19) occurred in 13% of patients treated with OJJAARA. Infections regardless of grade occurred in 38% of patients. Delay starting therapy until active infections have resolved. Monitor patients for signs and symptoms of infection and initiate appropriate treatment promptly.

    Hepatitis B Reactivation
  • Hepatitis B viral load (HBV-DNA titer) increases, with or without associated elevations in alanine transaminase (ALT) or aspartate transaminase (AST), have been reported in patients with chronic hepatitis B virus (HBV) infection taking Janus Kinase (JAK) inhibitors, including OJJAARA. The effect of OJJAARA on viral replication in patients with chronic HBV infection is unknown. In patients with HBV infections, check hepatitis B serologies prior to starting OJJAARA. If HBsAg and/or anti-HBc antibody is positive, consider consultation with a hepatologist regarding monitoring for reactivation versus prophylactic hepatitis B therapy. Patients with chronic HBV infection who receive OJJAARA should have their chronic HBV infection treated and monitored according to clinical HBV guidelines.

Thrombocytopenia and Neutropenia

  • New or worsening thrombocytopenia, with platelet count less than 50 × 109/L, was observed in 20% of patients treated with OJJAARA. Eight percent of patients had baseline platelet counts less than 50 × 109/L.
  • Severe neutropenia, absolute neutrophil count (ANC) less than 0.5 × 109/L, was observed in 2% of patients treated with OJJAARA.
  • Assess complete blood counts (CBC), including platelet and neutrophil counts, before initiating treatment and periodically during treatment as clinically indicated. Interrupt dosing or reduce the dose for thrombocytopenia or neutropenia.

Hepatotoxicity

  • Two of the 993 patients with MF who received at least one dose of OJJAARA in clinical trials experienced reversible drug-induced liver injury. Overall, new or worsening elevations of ALT and AST (all grades) occurred in 23% and 24%, respectively, of patients treated with OJJAARA; Grade 3 and 4 transaminase elevations occurred in 1% and 0.5% of patients, respectively. New or worsening elevations of total bilirubin occurred in 16% of patients treated with OJJAARA. All total bilirubin elevations were Grades 1-2. The median time to onset of any grade transaminase elevation was 2 months, with 75% of cases occurring within 4 months.
  • Delay starting therapy in patients presenting with uncontrolled acute and chronic liver disease until apparent causes have been investigated and treated as clinically indicated. When initiating OJJAARA, refer to dosing in patients with hepatic impairment.
  • Monitor liver tests at baseline, every month for 6 months during treatment, then periodically as clinically indicated. If increases in ALT, AST or bilirubin related to treatment are suspected, modify OJJAARA dosage based upon Table 1 within the Prescribing Information.

Severe Cutaneous Adverse Reactions (SCARs)

  • Severe cutaneous adverse reactions (SCARs), including toxic epidermal necrolysis (TEN), have been observed in some patients treated with OJJAARA.
  • If signs or symptoms of SCARs occur, interrupt OJJAARA until the etiology of the reaction has been determined. Consider early consultation with a dermatologist for evaluation and management.
  • If etiology is considered to be associated with OJJAARA, permanently discontinue OJJAARA and do not reintroduce OJJAARA in patients who have experienced SCARs or other life-threatening cutaneous reactions during treatment with OJJAARA.

Major Adverse Cardiovascular Events (MACE)

  • Another JAK inhibitor increased the risk of MACE, including cardiovascular death, myocardial infarction, and stroke [compared with those treated with tumor necrosis factor (TNF) blockers] in patients with rheumatoid arthritis, a condition for which OJJAARA is not indicated.
  • Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with OJJAARA, particularly in patients who are current or past smokers and patients with other cardiovascular risk factors. Inform patients receiving OJJAARA of the symptoms of serious cardiovascular events and the steps to take if they occur.

Thrombosis

  • Another JAK inhibitor increased the risk of thrombosis, including deep venous thrombosis, pulmonary embolism, and arterial thrombosis (compared with those treated with TNF blockers) in patients with rheumatoid arthritis, a condition for which OJJAARA is not indicated. Evaluate patients with symptoms of thrombosis and treat appropriately.

Malignancies

  • Another JAK inhibitor increased the risk of lymphoma and other malignancies excluding nonmelanoma skin cancer (NMSC) (compared with those treated with TNF blockers) in patients with rheumatoid arthritis, a condition for which OJJAARA is not indicated. Current or past smokers were at increased risk.
  • Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with OJJAARA, particularly in patients with a known malignancy (other than a successfully treated NMSC), patients who develop a malignancy, and patients who are current or past smokers.

Adverse Reactions

  • The most common adverse reactions (≥20% in either study) are thrombocytopenia, hemorrhage, bacterial infection, fatigue, dizziness, diarrhea, and nausea.

Organic Anion Transporting Polypeptide (OATP)1B1/B3 Inhibitors

  • Momelotinib is an OATP1B1/B3 substrate. Concomitant use with an OATP1B1/B3 inhibitor increases momelotinib maximal concentrations (Cmax) and area under the concentration-time curve (AUC), which may increase the risk of adverse reactions with OJJAARA. Monitor patients concomitantly receiving an OATP1B1/B3 inhibitor for adverse reactions and consider OJJAARA dose modifications.

Breast Cancer Resistance Protein (BCRP) Substrates

  • Momelotinib is a BCRP inhibitor. OJJAARA may increase exposure of BCRP substrates, which may increase the risk of BCRP substrate adverse reactions. When administered concomitantly with OJJAARA, initiate rosuvastatin (BCRP substrate) at 5 mg and do not increase to more than 10 mg once daily. Dose adjustment of other BCRP substrates may also be needed. Follow approved product information recommendations for other BCRP substrates.

Pregnancy

  • Available data in pregnant women are insufficient. OJJAARA should only be used during pregnancy if the expected benefits to the mother outweigh the potential risks to the fetus.

Lactation

  • It is not known whether OJJAARA is excreted in human milk. Because of the potential for serious adverse reactions in a breastfed child, patients should not breastfeed during treatment with OJJAARA, and for at least 1 week after the last dose of OJJAARA.

Females and Males of Reproductive Potential

  • Advise females of reproductive potential who are not pregnant to use highly effective contraception during therapy and for at least 1 week after the last dose of OJJAARA.

Hepatic Impairment

  • Momelotinib exposure increased with severe hepatic impairment (Child-Pugh C). The recommended starting dose of OJJAARA in patients with severe hepatic impairment (Child-Pugh C) is 150 mg orally once daily. No dose modification is recommended for patients with mild hepatic impairment (Child-Pugh A) or moderate hepatic impairment (Child-Pugh B).

Please see full Prescribing Information for OJJAARA.

To report SUSPECTED ADVERSE REACTIONS, contact GSK at gsk.public.reportum.com or 1-888-825-5249 or
FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Reference

  1. Passamonti F, Cervantes F, Vannucchi AM, et al. A dynamic prognostic model to predict survival in primary myelofibrosis: a study by the IWG-MRT (International Working Group for Myeloproliferative Neoplasms Research and Treatment). Blood. 2010;115(9):1703-1708. doi:10.1182/blood-2009-09-245837
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