Inflammatory Bowel Disease Drug Summary

Drug	Available Strength	Dosage	Remarks
Budesonide	2 mg/100 mL enema	Active UC: 2 mg enema rectally at bedtime x 4 weeks If patient is not in remission at 4 weeks, may continue x 8 weeks	Adverse Reactions GI effects (flatulence, nausea, diarrhea, rectal foam: Burning in rectum and pain); Dermatologic effects (urticaria, rash); CNS effects (agitation, insomnia) Rarely signs or symptoms of systemic corticosteroids Special Instructions Contraindicated in patients with systemic or local bacterial, fungal, viral or amoebic infections Use with caution in patients with slight to moderate hepatic impairment, severe liver function disorders
	2 mg/actuation rectal foam	Active UC: 2 mg (1 actuation) 24 hourly x 6-8 weeks
Hydrocortisone	100 mg/60 mL enema	Active UC: 100 mg enema rectally 12-24 hourly
	90 mg/900 mg foam	90 mg rectally 12-24 hourly x 2-3 weeks, then every second day thereafter
	25 mg, 30 mg suppository	1 suppository (25 or 30 mg) 12 hourly
Methylprednisolone	100 mg/60 mL enema	UC: 40-120 mg intrarectally, 3-7 times weekly
Prednisolone (Prednisolone metasulphobenzoate)	5 mg suppository	Insert 1 suppository at bedtime and 1 suppository in the morning after defecation
	20 mg/metered dose rectal foam	20 mg rectally 12-24 hourly x 2 weeks May extend for another 2 weeks when response is good
	20 mg/100 mL enema	20 mg rectally at bedtime x 2-4 weeks May continue if with good response

Drug	Dosage	Remarks
Beclometasone	Active mild-moderate UC: 5 mg PO 24 hourly in the morning Max duration: 4 weeks	Adverse Reactions Gastritis. If administered long-term: Adrenocortical insufficiency, osteoporosis, muscle wasting, pain or weakness, increased susceptibility to infection, impaired wound healing, electrolyte imbalances, weight gain, diabetes, skin thinning leading to striae and easy bruising, cataracts, glaucoma Special Instructions Take with food Patients on long-term corticosteroids should receive preventive treatment for osteoporosis Use with caution in patients with heart failure, acute MI, DM, GI diseases, hepatic/renal impairment, myasthenia gravis, osteoporosis, seizure disorder, thyroid disease Long-term treatment is not recommended due to its side effects
Betamethasone dipropionate/Betamethasone disodium phosphate	Betamethasone dipropionate 5 mg/Betamethasone disodium phosphate 2 mg UC and CD: 1-2 mL IM, repeat as necessary
Budesonide	Active mild-moderate UC: 9 mg PO 24 hourly in the morning x 8 weeks Active mild-moderate ileal and/or colonic CD: 9 mg PO 24 hourly in the morning or 3 mg PO 8 hourly x 8 weeks Maintenance of remission: 6 mg PO 24 hourly x 3 months
Dexamethasone	UC and CD: 0.75-9 mg/day PO in 2-4 divided doses or 0.5-9 mg/day IV/IM in 2-4 divided doses or 4 mg diluted in 150 mL saline administered as rectal drip in rectal UC
Hydrocortisone	Severe UC: 300-400 mg/day IV or 100 mg IV 6-8 hourly Continuous IV may be preferred over bolus dosing
Methylprednisolone	Severe UC: 4-48 mg PO 24 hourly or 40-60 mg/day IV or 40-120 mg IV continuous drip 3-7x weekly for periods of ≥2 weeks or as retention enemas Continuous IV may be preferred over bolus dosing Severe CD: 4-48 mg PO 24 hourly or 40-60 mg/day continuous IV infusion
Prednisolone (Prednisone)	Mild-moderate extensive colitis: 40-60 mg/day PO until with significant improvement; then taper dose to 5-10 mg/weekly until daily dose is 20 mg; then taper at a rate of 2.5 mg/week Severe UC: 30 mg IV 12 hourly Moderate-severe ileal and/or colonic CD: 40-60 mg/day PO x 8-12 weeks until with significant improvement; then taper dose to 5-10 mg/week until daily dose is 20 mg; then taper at a rate of 2.5 mg/week
Triamcinolone	UC and CD: 4-48 mg PO 24 hourly

Drug	Dosage	Remarks
Mercaptopurine	Induction of remission in UC 50 mg PO 24 hourly Max dose: 1.5 mg/kg/day Maintenance of remission in UC 1-1.5 mg/kg/day PO Maintenance of remission in CD 0.75-1.5 mg/kg/day PO in combination with anti-TNF agents Management of CD post-surgery 1.5 mg/kg/day PO in combination with Metronidazole x 18 months after surgery or 50 mg PO 24 hourly x 24 months Reduction of steroid use in CD or UC or fistulizing disease Initial dose: 50 mg/day PO May increase by 25 mg/day every 1-2 weeks as tolerated to target dose of 1-1.5 mg/kg/day	Adverse Reactions Hematologic effects (myelosuppression, leukopenia, thrombocytopenia, anemia); Hepatic effects (intrahepatic cholestasis, focal centrilobular necrosis); CNS effect (drug fever); GI effects (anorexia, diarrhea, nausea/vomiting, abdominal pain); Other effects (hyperuricemia, rash) Common signs of infection may not occur; lethargy and confusion may be more prominent signs of infection Special Instructions Contraindicated in patients whose disease showed prior resistance to Mercaptopurine or Thioguanine, patients with hepatic disease, severe bone marrow suppression Use with caution if used concomitantly with other hepatotoxic drugs There have been reports of increased risk of hepatosplenic T-cell lymphoma (HSTCL) development, particularly in adolescents and young adults Monitor for signs and symptoms of malignancy (eg splenomegaly, hepatomegaly, abdominal pain, persistent fever, night sweats, weight loss) Weekly CBC monitoring for the first 8 weeks of therapy followed by CBC at least every 3 months Assess LFT every 3 months
Methotrexate	Active CD 12.5-15 mg PO once weekly or Induction dose: 15-25 mg IM/SC once weekly Maintenance of remission: 15 mg PO weekly or 15-25 mg IM/SC once weekly	Adverse Reactions CNS effects (dizziness, fever, seizure); GI effects (nausea/vomiting, loss of appetite, abdominal pain, diarrhea); Hematologic effects (anemia, leukopenia, thrombocytopenia); Other effects (alopecia, potentially fatal dermatologic reactions eg toxic epidermal necrolysis and Stevens-Johnson syndrome, impairment of fertility, oligospermia) Low-dose Methotrexate has been associated with development of malignant lymphomas Use may predispose patients to opportunistic infection Special Instructions Contraindicated in patients with alcoholic liver disease, pre-existing blood dyscrasias Use with caution in patients with peptic ulcer disease, UC, renal impairment May cause folic acid deficiency, consider giving folate supplementation at 1-5 mg/day Monitor CBC with platelets, serum creatinine and LFT

Drug	Available Strength	Dosage	Remarks
Sodium butyrate (Na butyrate)	150 mg capsule	150 mg PO 12 hourly for at least 3 months	Special Instructions Should be taken with food Do not use as a substitute or alternative for a healthy balanced diet Do not give to patients with swallowing difficulties
Aminosalicylates - Oral
Balsalazide sodium	750 mg cap	Active mild-moderate UC: 2.25 g PO 8 hourly until remission or up to12 weeks Maintenance of remission: 1.5 g PO12 hourly May increase up to 6 g/day	Adverse Reactions CNS effect (headache); GI effects (anorexia, nausea/vomiting, diarrhea, abdominal pain); Hypersensitivity reactions Rarely blood dyscrasias, increased aminotransferases, skin reactions, myalgia, arthralgia, pancreatitis, pericarditis, interstitial nephritis Sulfasalazine: Metabolized into Sulfapyridine and Mesalazine. Many intolerable adverse effects are attributable to the Sulfapyridine moiety and are more common with high doses Dose-related: Nausea/vomiting, headache, blood dyscrasias Other effects: Toxic epidermal necrolysis, Stevens-Johnson syndrome, DRESS, aplastic anemia, hepatic and pulmonary dysfunction, autoimmune hemolysis, oligospermia, discoloration of body fluids Special Instructions Patients intolerant of Sulfasalazine should be initiated cautiously with other aminosalicylates Contraindicated in patients sensitive to sulfonamides or salicylates Use with caution in patients with hepatic or renal impairment, severe allergies or bronchial asthma, G6PD deficiency May cause folic acid deficiency, consider giving folate supplement Monitor LFT and CBC during the first 3 months of treatment, periodic monitoring of kidney function is recommended
Mesalazine (Mesalamine, 5-Aminosalicylic acid, 5-ASA)	250 and 500 mg enteric-coated tab	Active mild-moderate UC: 1.5-3 g/day PO divided 8 hourly Maintenance of remission: 500 mg PO 8 hourly Active mild-moderate ileal and/or colonic CD: 1.5-4.5 g/day PO divided 8 hourly
	400 mg, 800 mg, 1 g tab	Active mild-moderate UC: 2.4-4.8 g/day PO in divided doses Maintenance of remission UC: 1.2-2.4 g/day PO in divided doses Maintenance of remission CD: 2.4 g/day PO in divided doses
	500 mg, 1 g slow-release tab	Active mild-moderate UC: Up to 4 g/day PO in divided doses Maintenance of remission UC: 2 g/day PO in divided doses Treatment of active mild-moderate CD: Up to 4 g/day PO in divided doses
	500 mg,1 g, 1.5 g, 2 g, 3 g, 4 g granules	Active UC: 1.5-3 g PO 24 hourly or divided 8 hourly or Up to 4 g/day PO in divided doses Maintenance of remission: 0.5 g PO 8 hourly or 2-3 g PO 24 hourly CD: Up to 4 g/day PO in divided doses
	1.2 g prolonged-release tab	Active mild-moderate UC: 2.4-4.8 g PO 24 hourly Maintenance of remission UC: 2.4 g/day
Olsalazine	250 mg capsule	Active mild-moderate UC: 1 g/day PO divided 12 hourly Max dose: 3 g/day Maintenance of remission: 500 mg PO 12 hourly
Sulfasalazine	500 mg tablet and 500 mg enteric-coated tablet, caplet	Active mild-moderate UC: 1-2 g PO 6-8 hourly with or without steroids May give initial dose of 500 mg PO 6-8 hourly to reduce adverse effects (doses >4 g/day are associated with increased toxicity) Maintenance of remission: 2 g/day in divided doses Active mild-moderate ileal and/or colonic CD: 1-2 g PO 6-8 hourly then 500 mg-1 g PO 8 hourly May give initial dose of 500 mg PO 6-12 hourly and increase gradually to reduce adverse effects (doses >4 g/day are associated with increased toxicity) Severe CD and UC: 1-2 g PO 6-8 hourly with steroids
Aminosalicylates - Rectal
Mesalazine (Mesalamine, 5-Aminosalicylic acid, 5-ASA)	1, 2 and 4 g enema	1-4 g rectally 24 hourly at bedtime	Adverse Reactions Minor irritation, itching, frequent urge, discomfort Special Instructions Contraindicated in patients sensitive to salicylates and its derivatives Avoid in bronchial asthmatics as sulfite contained in enemas may cause hypersensitivity reactions
	250, 500 mg and 1 g suppository	Active mild-moderate UC: 250 mg-1 g rectally 8-24 hourly Maintenance of remission: 250 mg rectally 8 hourly

Drug	Dosage	Remarks
Adalimumab (Adalimumab-adaz, Adalimumab-adbm, Adalimumab-afzb, Adalimumab-atto, Adalimumab-bwwd)	Moderate-severe UC Induction dose: 160 mg SC at week 0 (dose can be administered as four 40-mg injections in 1 day or as two 40-mg injections/day for 2 consecutive days) followed by 80 mg SC at week 2 Maintenance dose: 40 mg SC every 2 weeks beginning at week 4 Some patients who experience decrease in response may benefit from an increase in dose of 40 mg every week or 80 mg every 2 weeks Moderate-severe CD Induction dose: 80 mg SC at week 0 followed by 40 mg SC at week 2 For rapid response to therapy, may give 160 mg SC at week 0 (administer by either dividing dose into 4 injections in 1 day or as two 40-mg injections/day for 2 days), then follow with 80 mg SC at week 2 Maintenance dose: 40 mg SC every 2 weeks beginning at week 4 Some patients who experience decrease in response may benefit from an increase in dose of 40 mg every week or 80 mg every 2 weeks Some patients who have not responded by week 4 may benefit from continued maintenance therapy through week 12 Continued therapy should be carefully reconsidered in a patient not responding within this time period	Adverse Reactions CNS effects (headache, dizziness); GI effects (abdominal discomfort, nausea/vomiting); Other effects (local injection site reactions, allergic reactions, rash, upper respiratory infection, sinusitis) Serious and potentially fatal infections (eg bacterial, mycobacterial, viral, fungal infections) have been reported Reports of reactivation of latent TB infection and new infection have been noted Special Instructions Contraindicated in patients with active TB or other severe infections (eg sepsis, opportunistic infections), moderate to severe heart failure (HF) Use with caution in patients with blood dyscrasias, HF, history of new/recurrent infections, with conditions that predispose to infection, demyelinating CNS disorders There have been reports of increased risk of HSTCL development, particularly in adolescents and young adults Monitor for signs and symptoms of malignancy (eg splenomegaly, hepatomegaly, abdominal pain, persistent fever, night sweats, weight loss) Hepatitis B and TB screening prior to treatment
Azathioprine	Maintenance of remission or reduction of steroid use in UC: 50 mg PO 24 hourly or 1.5-2.5 mg/kg/day PO Severe CD/induction or maintenance of remission or steroid-sparing therapy of CD: 50 mg PO 24 hourly or 1.5-2.5 mg/kg/day PO in combination with an anti-TNF agent Management of CD post-surgery: 50 mg PO 24 hourly, increased to 2-2.5 mg/kg/day over ≥12 weeks in combination with Metronidazole x 3 months after surgery	Adverse Reactions CNS effects (fever, malaise); GI effects (nausea/vomiting, diarrhea); Hematologic effects (leukopenia, thrombocytopenia); Other effects (increased LFT, myalgia, rarely pancreatitis) Increased risk of neoplasia with chronic use Special Instructions Use with caution in patients with hepatic or renal impairment, with TPMT deficiency There have been reports of increased risk of HSTCL development, particularly in adolescents and young adults Monitor for signs and symptoms of malignancy (eg splenomegaly, hepatomegaly, abdominal pain, persistent fever, night sweats, weight loss) Monitor CBC and platelets, LFT, total bilirubin, TPMT genotyping or phenotyping
Certolizumab pegol	Active moderate-severe CD Initial dose: 400 mg SC, repeat dose 2 and 4 weeks after initial dose Maintenance of remission: 400 mg SC every 4 weeks	Adverse Reactions Infections: Respiratory tract infections, urinary tract infections (UTIs), TB which seems to be recurrence of latent disease, viral, bacterial, fungal and protozoal infections have also occurred; serious infections including sepsis can occur Formation of antinuclear antibodies (ANA) and anti-ds DNA antibodies; lupus-like syndrome has occurred that improved following discontinuation and appropriate therapy Worsening of chronic heart failure (CHF) can occur in CHF patients Other effects: Depression, insomnia, GI effects (nausea/vomiting, abdominal pain, dyspepsia); Rarely hepatotoxicity, optic neuritis, blood dyscrasias Special Instructions Contraindicated in patients with moderate-severe CHF, patients with hypersensitivity to murine proteins, active TB, opportunistic infections and undrained abscesses Use with caution in patients with chronic infection or history of recurrent infection, with pre-existing or recent onset of CNS demyelinating diseases, seizure disorders Patient should be monitored for signs and symptoms of infections while on and after treatment Discontinue therapy if serious infection develops There have been reports of increased risk of HSTCL development, particularly in adolescents and young adults Monitor for signs and symptoms of malignancy (eg splenomegaly, hepatomegaly, abdominal pain, persistent fever, night sweats, weight loss)
Ciclosporin (Cyclosporine)	Severe UC (steroid-refractory): 2-4 mg/kg/day IV infusion over 24 hours or 2.3-3 mg/kg PO 12 hourly Refractory, inflammatory, fistulizing CD: 4 mg/kg/day IV infusion over 24 hours x 2-10 days Patients responsive to IV therapy should be switched to oral therapy	Adverse Reactions GI effects (abdominal pain, diarrhea, nausea, dyspepsia); CNS effects (tremors, headache); CV effects (hypertension, edema); Other effects (gingival hyperplasia, hirsutism, hypertrichosis, renal dysfunction, nephropathy, elevated creatinine, increased triglycerides, infection) Special Instructions Avoid prolonged sun exposure, tanning booths and sunlamps Avoid in patients with renal dysfunction, uncontrolled hypertension, uncontrolled infections, persistently raised creatinine, malignancy, porphyria Vaccination with live-virus vaccines is not recommended Monitor renal and hepatic function, BP, serum electrolytes and lipids regularly Commercially available oral products differ in their bioavailability; use caution when switching from one product to another
Etrasimod	Moderate-severe UC:  2 mg PO 24 hourly	Adverse Reactions CNS effects (headache, dizziness); CV effects (bradycardia, hypertension); Other effects (nausea, infection, elevated LFTs, arthralgia, decreased visual acuity) Special Instructions Contraindicated in patients who in the last 6 months have experienced MI, unstable angina, stroke, transient ischemic attack (TIA), decompensated HF needing hospitalization, or class III or IV HF; history or presence of Mobitz type II 2nd-degree or 3rd-degree atrioventricular (AV) block, sick sinus syndrome or sino-atrial block, unless patient has a functioning pacemaker Use of live attenuated vaccines during treatment and up to 5 weeks after treatment is not recommended Do not start in patients with active infections; discontinue if significant liver injury is confirmed Assessments (eg CBC, ECG, LFTs, spirometry, skin examination or ophthalmic evaluation [if clinically indicated]) are required before starting therapy; monitor BP during treatment
Filgotinib maleate	Moderate-severe UC Initial dose: 200 mg PO 24 hourly x 10 weeks Max treatment duration: 22 weeks Maintenance dose: 100-200 mg PO 24 hourly	Adverse Reactions Respiratory effects (URTI, pneumonia); Hematologic effects (lymphopenia, neutropenia); Other effects (dizziness, nausea, herpes zoster, sepsis, UTI, hypercholesterolemia, increased blood creatine phosphokinase) Special Instructions Should only be used if no suitable treatment alternatives are available in patients ≥65 years old, with history of atherosclerotic CV disease or other CV risk factors (eg current or chronic smokers), with malignancy risk factors Use with caution in patients at increased risk for VTE or GI perforation Contraindicated in patients with hypersensitivity to Filgotinib maleate, active TB or active serious infections, pregnancy Use of live vaccines during or immediately prior to treatment is not recommended
Golimumab	Moderate-severe UC Initial dose: 200 mg SC injection at week 0, followed by 100 mg SC at week 2 Maintenance dose: 50 mg (<80 kg) or 100 mg (≥80 kg) SC every 4 weeks	Adverse Reactions Respiratory effects (URTI, bronchitis); Other effects (bacterial infection, viral infections, superficial fungal infections, increased ALT and AST, anemia, non-serious allergic reactions, positive autoantibody, dizziness, HTN, rash, pyrexia, injection site reactions) Special Instructions Use with caution in patients with active infection, invasive fungal infections, malignancies, central or peripheral nervous system demyelinating disorders and significant hematologic cytopenias Concomitant use with Abatacept, Anakinra and live vaccines is not recommended Discontinue if new/worsening symptoms of CHF appear Evaluate for TB risk factors and test for latent infection prior to and during therapy Monitor HBV carriers for signs of HBV reactivation
Guselkumab	Moderate-severe UC Induction dose: 200 mg IV infusion over at least 1 hour at 0, 4 and 8 weeks Maintenance dose: 100 mg SC at 16 weeks and every 8 weeks thereafter or 200 mg SC at 12 weeks and every 4 weeks thereafter Use lowest effective dose to maintain response Moderate-severe CD Induction dose: 200 mg IV infusion over at least 1 hour at week 0, 4 and 8 or 400 mg SC (given as 2 200 mg consecutive injections) at week 0, 4 and 8 Maintenance dose: 100 mg SC at 16 weeks and every 8 weeks thereafter or 200 mg SC at 12 weeks and every 4 weeks thereafter Use lowest effective dose to maintain response	Adverse Reactions GI effects (abdominal pain, diarrhea); Respiratory effect (respiratory tract infections); Other effects (injection site reactions, arthralgia, fatigue, headache) Special Instructions Contraindicated in patients with hypersensitivity to Guselkumab Monitor LFTs and bilirubin levels at baseline, for at least 16 weeks of treatment and periodically thereafter Avoid concurrent use of live vaccines Screen for TB prior to treatment
Infliximab (Infliximab-abda, Infliximab-axxq, Infliximab-dyyb, Infliximab-qbtx)	UC 5 mg/kg IV infusion over a 2-hour period at 0, 2 and 6 weeks then 8 weekly thereafter For patients who do not respond after 3 doses, no additional dose should be given Moderate-severe CD Induction dose: 5 mg/kg IV infusion over a 2-hour period, repeated after 2 weeks For patients who do not respond after 2 doses, no additional dose should be given Maintenance dose: 5 mg/kg IV infusion at 6 weeks after initial dose then 8 weekly thereafter Fistulizing CD 5 mg/kg IV infusion over a 2-hour period at 0, 2 and 6 weeks For patients who do not respond after 3 doses, no additional dose should be given Maintenance dose: 5 mg/kg IV infusion 8 weekly Re-administration for fistulizing CD: 5 mg/kg IV infusion if signs/symptoms recur, followed by 5 mg/kg IV 8 weekly	Adverse Reactions CNS effects (headache, dizziness); GI effects (abdominal pain, diarrhea, dyspepsia, nausea/vomiting); Respiratory effects (pharyngitis, coughing, bronchitis); Other effects (local injection site reaction, allergic reactions, flushing) Serious and potentially fatal infections (eg bacterial, mycobacterial, viral, fungal infections) have been reported Reports of TB reactivation of latent infection and new infection have been noted Special Instructions Contraindicated in patients with hypersensitivity to murine proteins Patients with moderate/severe CHF should not receive doses of >5 mg/kg Avoid use with Anakinra, Abatacept and live vaccines Hepatitis and TB screening prior to treatment
Mirikizumab (Mirikizumab-mrkz)	Moderate-severe UC Induction dose: 300 mg IV infusion over at least 30 minutes at 0, 4 and 8 weeks Maintenance dose: 200 mg SC (given as 2 100 mg consecutive injections) at 12 weeks after initial dose then 4 weekly thereafter Active moderate-severe CD Induction dose: 900 mg IV at 0, 4 and 8 weeks Maintenance dose: 300 mg SC at 12 weeks after initial dose then 4 weekly thereafter	Adverse Reactions Respiratory effect (upper respiratory infections); Other effects (arthralgia, injection site reactions, rash, headache, herpes viral infection) Special Instructions Contraindicated in patients with hypersensitivity to Mirikizumab, clinically active infection TB screening prior to treatment and monitor for signs and symptoms of TB during and after treatment Monitor LFTs and bilirubin levels at baseline, at 24 weeks of treatment and as necessary thereafter Avoid concurrent use of live vaccines
Natalizumab	Active moderate-severe CD: 300 mg IV infusion over 1 hour every 4 weeks Discontinue if benefit is not observed within initial 12 weeks of therapy	Adverse Reactions CNS effects (headache, fatigue, depression); Dermatologic effect (rash); GI effects (nausea, abdominal discomfort); Other effects (infusion-related reaction, infections, arthralgia, back pain, hepatotoxicity) Special Instructions Contraindicated in patients with hypersensitivity to murine proteins, with current or history of progressive multifocal leukoencephalopathy (PML) Use with caution in patients with depression Should not be used in combination with immunosuppressants or TNF inhibitors Aminosalicylates may be used concurrently with Natalizumab Patients should be monitored for signs and symptoms of PML and infections while on and after treatment Discontinue therapy if serious infection develops
Ozanimod	Moderate-severe UC: Titration is required for treatment initiation: 0.23 mg PO 24 hourly on days 1-4, 0.46 mg PO 24 hourly on days 5-7 then 0.92 mg PO 24 hourly on day 8 and thereafter If a dose is missed within the first 2 weeks of treatment, reinitiate with the titration regimen. If a dose is missed after the first 2 weeks of treatment, continue treatment as planned	Adverse Reactions GI effects (nausea, increased liver test); Other effects (headache, upper respiratory infection, pyrexia, arthralgia) May increase the risk of infection, result in transient decrease in heart rate, cause visual changes or a decline in pulmonary function Special Instructions Assessments (eg CBC, ECG, LFTs, test for varicella-zoster virus antibodies, spirometry or ophthalmic evaluation [if clinically indicated]) are required before starting Ozanimod; monitor BP during treatment Contraindicated in patients who in the last 6 months have experienced MI, unstable angina, stroke, TIA, decompensated HF needing hospitalization, or class III or IV HF; presence of Mobitz type II 2nd-degree or 3rd-degree AV block, sick sinus syndrome or sino-atrial block, unless patient has a functioning pacemaker; severe untreated sleep apnea; concomitant use of a monoamine oxidase inhibitor Do not start in patients with active infections; discontinue if significant liver injury is confirmed
Risankizumab (Risankizumab-rzaa)	Moderate-severe UC Induction dose: 1,200 mg IV infusion over at least 2 hours at 0, 4 and 8 weeks Maintenance dose: 180-360 mg SC at 12 weeks and every 8 weeks thereafter Use lowest effective dose to maintain response Moderate-severe CD Induction dose: 600 mg IV infusion over at least 1 hour at 0, 4 and 8 weeks Maintenance dose: 180-360 mg SC at week 12 and every 8 weeks thereafter Use lowest effective dose to maintain response	Adverse Reactions Induction: Upper respiratory infections, headache, arthralgia Maintenance: Arthralgia, back pain, arthropathy, injection site reactions, abdominal pain, anemia, pyrexia, UTI Special Instructions Obtain liver enzymes and bilirubin levels and screen for TB prior to starting treatment Monitor liver enzymes and bilirubin levels during induction and up to at least 12 weeks of treatment Avoid in patients with clinically active infection Avoid concomitant use of live vaccines
Tacrolimus	Active UC: 0.05 mg/kg/day PO May increase dose after 24 hours Fistulizing CD: 200 mcg/kg/day PO in 2 divided doses x 10 weeks	Adverse Reactions CNS effects (headache, tremor, paresthesias); Dermatologic effects (rash, pruritus, hirsutism, alopecia); GI effects (nausea, diarrhea, constipation); CV effects (hypertension, ECG changes); Hematologic effects (blood dyscrasias, leukocytosis); Other effects (electrolyte disturbances, infusion-related reaction, infectious complications, hepatotoxicity, increased incidence of malignancy) Special Instructions Should be taken on an empty stomach at least 1 hour before or 2-3 hours after meals Avoid ingestion of grapefruit or grapefruit juice while on therapy Monitor blood trough serum concentrations while on therapy
Tofacitinib	Moderate-severe UC: 10 mg PO 12 hourly x ≥8 weeks Max treatment duration: 16 weeks Maintenance dose: 5 mg PO 12 hourly May increase to 10 mg PO 12 hourly if with decreased response to maintenance dose or if failed prior TNF inhibitor therapy Use lowest effective dose to maintain response	Adverse Reactions CV effects (decreased heart rate, prolonged PR interval), GI effects (GI perforation, nausea/vomiting); Respiratory effects (nasopharyngitis, URTI); Other effects (infection, malignancy, Epstein-Barr virus-associated post-transplant lymphoproliferative disorder, bone marrow suppression, elevated liver enzymes, lipid abnormalities, hypersensitivity reactions) Special Instructions Discontinue therapy if inadequate response is achieved after 16 weeks using 10 mg PO 12 hourly Contraindicated in patients with severe hepatic impairment, pregnancy and lactation Avoid in patients with active, serious infection including localized infection Avoid concurrent administration of live vaccines and immunosuppressants Use with caution in patients at risk for GI perforation, patients with history of chronic pulmonary disease, renal impairment, hyperlipidemia or hypercholesterolemia, diabetes Increased risk of infections and malignancy, or reactivating latent infections Evaluate patient for TB prior to therapy Determine Hb, neutrophil and lymphocyte counts before initiating treatment; treatment should not be started in patients with anemia (Hb <9 g/dL), lymphocyte count <500 cells/mm3 or neutropenia (<1,000 cells/mm3)
Upadacitinib	Moderate-severe UC 45 mg PO 24 hourly x 8 weeks Max treatment duration: 16 weeks Maintenance dose: 15 mg PO 24 hourly May increase to 30 mg PO 24 hourly in patients with high disease burden (eg severe disease, pancolitis) or requiring 16-week induction treatment or with inadequate response to 15 mg/day dose; discontinue use if adequate response is not achieved with 30 mg dose Moderate-severe CD 45 mg PO 24 hourly x 12 weeks Maintenance dose: 15 mg PO 24 hourly May increase to 30 mg PO 24 hourly in patients with refractory, severe or extensive disease; discontinue use if adequate response is not achieved with 30 mg dose	Adverse Reactions GI effects (GI perforation, nausea); Hematologic effects (lymphopenia, anemia, neutropenia); Other effects (reactivation of viral infection, malignancy, elevated liver enzymes, lipid abnormalities) Special Instructions Use lowest effective dose to maintain response UC: Discontinue therapy if inadequate response is achieved after 16 weeks using 45 mg PO 24 hourly Contraindicated in patients with severe hepatic impairment, with active serious infection including localized infection, pregnancy and lactation Avoid concurrent administration of live vaccines and immunosuppressants Use with caution in patients at risk for GI perforation, known malignancy, patients with risk factors for CV disorders, chronic or recurrent infection, history of serious or opportunistic infection, exposure to TB or have resided or traveled in areas of endemic TB or mycoses, risk factors for DVT or pulmonary embolism, severe renal impairment Increased risk of infections Assess for signs and symptoms of infection, TB and thrombosis during and after therapy, and perform periodic skin exam in patients at increased risk for skin cancer Evaluate patient for TB and viral hepatitis prior to therapy Determine CBC, neutrophil and lymphocyte counts, LFTs before initiating treatment and periodically thereafter Treatment should not be started in patients with absolute neutrophil count <1 x 109 cells/L, Hb <8 g/dL or absolute lymphocyte count <0.5 x 109 cells/L
Ustekinumab	Moderate-severe UC and CD Induction dose: Based on body weight, administered over at least 1 hour as a single dose via infusion: ≤55 kg: 260 mg IV >55-85 kg: 390 mg IV >85 kg: 520 mg IV Maintenance dose: 90 mg SC starting 8 weeks after the initial IV induction dose and then every 8-12 weeks thereafter depending on response	Adverse Reactions Respiratory effects (URTI, nasopharyngitis); CNS effects (dizziness, headache); GI effects (oropharyngeal pain, diarrhea, nausea/vomiting); Musculoskeletal effects (back pain, myalgia, arthralgia); Other effects (pruritus, fatigue, injection site erythema, pain) Special Instructions Use with caution in patients with history of chronic/recurrent severe infections, concomitant use of immunosuppressants and when transitioning from other biologic agents Contraindicated in patients with history of hypersensitivity to Ustekinumab and its excipients and in patients with severe infections such as sepsis, TB and opportunistic infections Potential to increase risk of infections and reactivate latent infections; history and increased risk of malignancy Evaluate patient for TB prior to therapy Avoid concurrent immunization with live vaccines
Vedolizumab	Moderate-severe UC and CD: 300 mg IV infusion over 30 minutes at 0, 2 and 6 weeks and then every 8 weeks thereafter or every 4 weeks if response declines or Maintenance dose: 108 mg SC every 2 weeks after at least 2 IV infusions, administered in place of next scheduled IV dose then every 2 weeks thereafter	Adverse Reactions GI effects (gastroenteritis, oropharyngeal pain, nausea, dyspepsia, constipation, abdominal distention, flatulence, hemorrhoids, anal abscess and fissure); Respiratory effects (URTI, influenza, sinusitis, cough); CNS effects (headache, paresthesia); Dermatologic effects (rash, pruritus, eczema, erythema); Musculoskeletal effects (arthralgia, muscle spasms, back pain); Other effects (hypertension, night sweats, acne, fatigue, pyrexia) Special Instructions Contraindicated in patients with severe infection (sepsis, TB, opportunistic infection) Discontinue therapy if no evidence of therapeutic benefit is seen by week 14 Use with caution in patients with history of chronic/recurrent severe infections, patients previously treated with Natalizumab or Rituximab, concomitant with biologic immunosuppressants, live oral vaccines Increased risk of malignancy Do TB screening prior to treatment

Drug	Dosage	Remarks
Rifaximin	400 mg PO 8-12 hourly for 7-14 days	Adverse Reactions CNS effects (dizziness, headache); GI effects (abdominal pain, pseudomembranous colitis, bloating, constipation, diarrhea, urgency to evacuate feces, involuntary and painful/ineffective straining, nausea/vomiting); Other effects (fever, overgrowth of non-susceptible organisms) Special Instructions Contraindicated in patients with infectious/traveler’s diarrhea with fever and/or bloody stools Use with caution in patients taking estrogen-based contraceptive medications

All dosage recommendations are for non-pregnant and non-breastfeeding women, and non-elderly adults with normal renal and hepatic function unless otherwise stated.  
Not all products are available or approved for above use in all countries.  
Products listed in the Drug Summary are based on indications stated in the locally approved product monographs.   
Please refer to local product monographs in Related MIMS Drugs for country-specific prescribing information.