FDA-Approved Indications for Immunosuppressive and Antiemetic Agents
Azathioprine
Azathioprine is FDA-approved for transplant rejection prophylaxis, rheumatoid arthritis, and has licensed dermatologic indications including dermatomyositis, systemic lupus erythematosus, and pemphigus vulgaris 1.
- Transplant medicine: Prevention of organ rejection following kidney transplantation (original indication from early 1960s)
- Rheumatology: Rheumatoid arthritis (as steroid-sparing agent)
- Dermatology licensed indications 1:
- Dermatomyositis
- Systemic lupus erythematosus
- Pemphigus vulgaris
- Common off-label dermatologic uses 1, 2:
- Atopic eczema (frequently used as monotherapy)
- Cutaneous lupus
- Pyoderma gangrenosum
- Pityriasis rubra pilaris
- Severe cutaneous leucocytoclastic vasculitis
- Vasculitis: Wegener's granulomatosis (maintenance therapy), Behçet disease 2
Important prescribing note: Therapeutic effect is delayed for weeks to 2-3 months, and azathioprine provides a steroid-sparing effect that reduces long-term corticosteroid toxicity 1.
Infliximab (Remicade)
Infliximab is approved for multiple inflammatory conditions including Crohn's disease, ulcerative colitis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis 3, 4.
- Inflammatory bowel disease 3:
- Moderate-to-severe ulcerative colitis (strong recommendation, moderate-to-high certainty evidence)
- Moderate-to-severe Crohn's disease (active luminal disease and enterocutaneous fistulization)
- Rheumatology 4:
- Rheumatoid arthritis (in combination with methotrexate)
- Psoriatic arthritis
- Ankylosing spondylitis
- Dermatology: Plaque psoriasis
- Extraintestinal manifestations: Pyoderma gangrenosum, uveitis, arthropathy associated with Crohn's disease 5
Key prescribing consideration: The 2024 AGA guidelines recommend infliximab as a higher-efficacy medication for treatment-naïve UC patients, and suggest combination therapy with an immunomodulator (azathioprine or methotrexate) over monotherapy 3.
Certolizumab Pegol (Cimzia)
Certolizumab pegol is FDA-approved for Crohn's disease, rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis 6, 7.
- Inflammatory bowel disease: Crohn's disease (induction and maintenance therapy)
- Rheumatology 6:
- Rheumatoid arthritis (with or without concomitant methotrexate)
- Psoriatic arthritis
- Axial spondyloarthritis (including ankylosing spondylitis and non-radiographic axial spondyloarthritis)
- Dermatology: Plaque psoriasis 7
Unique structural feature: Certolizumab is a PEGylated Fab' fragment that lacks the Fc region, meaning it does not cross the placenta and can be safely used in pregnant women 6, 7.
Golimumab (Simponi)
Golimumab is approved for ulcerative colitis, rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis 3, 4.
- Inflammatory bowel disease: Moderate-to-severe ulcerative colitis (intermediate-efficacy medication per 2024 AGA guidelines) 3
- Rheumatology 4:
- Rheumatoid arthritis (in combination with methotrexate)
- Psoriatic arthritis
- Ankylosing spondylitis
Clinical positioning: The 2024 AGA guidelines classify golimumab as an intermediate-efficacy medication for treatment-naïve UC patients 3.
Adalimumab (Humira)
Adalimumab is approved for Crohn's disease, ulcerative colitis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis, hidradenitis suppurativa, and uveitis 3, 4.
- Inflammatory bowel disease 3:
- Moderate-to-severe ulcerative colitis (conditional recommendation, moderate certainty evidence—classified as lower-efficacy medication)
- Moderate-to-severe Crohn's disease
- Rheumatology 4:
- Rheumatoid arthritis
- Psoriatic arthritis
- Ankylosing spondylitis
- Dermatology:
- Plaque psoriasis
- Hidradenitis suppurativa
- Ophthalmology: Non-infectious uveitis
Important caveat: The 2024 AGA guidelines rank adalimumab as a lower-efficacy medication compared to other biologics for UC, with efficacy below the clinically meaningful difference threshold 3.
Natalizumab
Natalizumab is FDA-approved for relapsing forms of multiple sclerosis and moderate-to-severe Crohn's disease 8.
- Neurology: Relapsing forms of multiple sclerosis (to delay physical disability and reduce relapse frequency)
- Inflammatory bowel disease: Moderate-to-severe Crohn's disease (in patients with inadequate response to or intolerance of conventional therapy and TNF-α inhibitors)
Critical safety restriction: Natalizumab carries a black box warning for progressive multifocal leukoencephalopathy (PML). It is available only through a restricted distribution program (TOUCH Prescribing Program in the US) due to PML risk.
Tofacitinib (Xeljanz)
Tofacitinib is approved for rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, ankylosing spondylitis, and polyarticular juvenile idiopathic arthritis 3, 9.
- Inflammatory bowel disease: Moderate-to-severe ulcerative colitis (intermediate-efficacy medication for treatment-naïve patients; higher-efficacy for TNF-exposed patients) 3
- Rheumatology 4, 9:
- Rheumatoid arthritis (moderate-to-severe, with inadequate response to methotrexate)
- Psoriatic arthritis
- Ankylosing spondylitis
- Polyarticular juvenile idiopathic arthritis (age ≥2 years)
FDA restriction: The FDA label recommends using tofacitinib only in patients with prior failure or intolerance to TNF antagonists, not as first-line therapy 3.
Upadacitinib (Rinvoq)
Upadacitinib is FDA-approved for rheumatoid arthritis, psoriatic arthritis, atopic dermatitis, ulcerative colitis, Crohn's disease, ankylosing spondylitis, non-radiographic axial spondyloarthritis, and polyarticular juvenile idiopathic arthritis 10.
- Inflammatory bowel disease 3, 10:
- Moderate-to-severe ulcerative colitis (higher-efficacy medication; induction: 45 mg daily × 8 weeks, maintenance: 15 mg daily, consider 30 mg daily for refractory/severe disease)
- Moderate-to-severe Crohn's disease (induction: 45 mg daily × 12 weeks, maintenance: 15 mg daily, consider 30 mg daily for refractory/severe disease)
- Rheumatology 10:
- Rheumatoid arthritis (moderate-to-severe, inadequate response to TNF blockers; 15 mg daily)
- Psoriatic arthritis (age ≥2 years, inadequate response to TNF blockers)
- Ankylosing spondylitis (inadequate response to TNF blockers; 15 mg daily)
- Non-radiographic axial spondyloarthritis with objective inflammation (inadequate response to TNF blockers; 15 mg daily)
- Polyarticular juvenile idiopathic arthritis (age ≥2 years, inadequate response to TNF blockers)
- Dermatology 10:
- Refractory moderate-to-severe atopic dermatitis (age ≥12 years, weight ≥40 kg; start 15 mg daily, may increase to 30 mg daily if inadequate response; adults ≥65 years: 15 mg daily only)
FDA restriction: Not recommended for use in combination with other JAK inhibitors, biologic DMARDs, or potent immunosuppressants (azathioprine, cyclosporine) 10.
Methotrexate
Methotrexate is FDA-approved for neoplastic diseases, rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, and psoriasis.
- Oncology: Acute lymphoblastic leukemia, breast cancer, lung cancer, head and neck cancer, osteosarcoma, non-Hodgkin lymphoma, gestational trophoblastic disease
- Rheumatology:
- Rheumatoid arthritis (should be part of first treatment strategy per EULAR 2017 guidelines) 4
- Polyarticular juvenile idiopathic arthritis
- Dermatology: Severe psoriasis (recalcitrant, disabling)
- Off-label uses: Dermatomyositis/polymyositis (comparable efficacy to azathioprine) 2, Crohn's disease (though 2024 AGA guidelines suggest against methotrexate monotherapy for UC induction or maintenance) 3
Important note: The 2024 AGA guidelines specifically recommend against using methotrexate monotherapy for induction or maintenance of remission in ulcerative colitis 3.
Metoclopramide (Reglan)
Metoclopramide is FDA-approved for diabetic gastroparesis, gastroesophageal reflux disease, and prevention of chemotherapy-induced nausea/vomiting.
- Gastrointestinal motility: Symptomatic gastroesophageal reflux disease (short-term therapy, 4-12 weeks)
- Diabetic gastroparesis: Acute and recurrent diabetic gastroparesis (relief of symptoms)
- Antiemetic: Prevention of nausea and vomiting associated with emetogenic cancer chemotherapy, postoperative nausea/vomiting, radiotherapy-induced nausea/vomiting
- Procedural: Facilitation of small bowel intubation, radiological examination of the gastrointestinal tract
Black box warning: Tardive dyskinesia risk increases with treatment duration beyond 12 weeks and total cumulative dose. Use should be limited to ≤12 weeks except in rare cases.
Phenothiazines (Injectable Promethazine)
Promethazine is FDA-approved for allergic conditions, motion sickness, nausea/vomiting, sedation, and as an adjunct to anesthesia.
- Allergy: Amelioration of allergic reactions to blood or plasma, anaphylaxis (adjunctive therapy after epinephrine), allergic rhinitis (seasonal and perennial)
- Antiemetic: Prevention and control of nausea and vomiting associated with surgery, anesthesia, motion sickness
- Sedation: Preoperative, postoperative, and obstetric sedation; adjunct to analgesics for postoperative pain control
- Motion sickness: Active and prophylactic treatment
Black box warning for injectable promethazine: Severe tissue injury including gangrene can occur with extravasation. Preferred route is deep intramuscular injection; intravenous administration should be avoided if possible, and if necessary, must be given through a running IV line at concentrations ≤25 mg/mL and rates ≤25 mg/minute. Subcutaneous administration is contraindicated.