by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Avoid vaccination during chemotherapy or radiation therapy if possible because antibody response might be suboptimal. Patients vaccinated within a 14-day period before starting or during immunosuppressive therapy should be revaccinated =3 months after therapy is discontinued if immune competence has been restored. . ustekinumab decreases effects of haemophilus influenzae type b vaccine by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Avoid vaccination during chemotherapy or radiation therapy if possible because antibody response might be suboptimal. Patients vaccinated within a 14-day period before starting or during immunosuppressive therapy should be revaccinated =3 months after therapy is discontinued if immune competence has been restored. .Serious - Use Alternative (2)ustekinumab decreases effects of hepatitis b vaccine by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines. ustekinumab decreases effects of diphtheria & tetanus toxoids/ acellular pertussis vaccine by pharmacodynamic antagonism. Contraindicated. Prior initiating therapy, patients should receive all age-appropriate immunizations as recommended by current guidelines. Immunosuppressants also increase risk of infection with concomitant live vaccines.venetoclaxMonitor Closely (2)venetoclax decreases effects of poliovirus vaccine inactivated by pharmacodynamic antagonism. Use Caution/Monitor. Vaccines administered during venetoclax therapy may be less effective. venetoclax decreases effects of haemophilus influenzae type b vaccine by pharmacodynamic antagonism. Use Caution/Monitor.voclosporinMonitor Closely (3)voclosporin decreases effects of hepatitis b vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Inactivated vaccines noted to be safe for administration may not be sufficiently immunogenic during treatment. voclosporin decreases effects of poliovirus vaccine inactivated by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Inactivated vaccines noted to be safe for administration may not be sufficiently immunogenic during treatment. voclosporin decreases effects of haemophilus influenzae type b vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Inactivated vaccines noted to be safe for administration may not be sufficiently immunogenic during treatment. >10% Irritability (≥55%) Crying (≥45%) Injection site pain (≥44%) Somnolence (≥40%) Injection site erythema (≥25%) Decreased appetite (≥23%) Fever ≥38°C (100.4°F) (≥19%) Injection site swelling (≥18%) 1-10% Vomiting (≥9%) Postmarketing Reports Immune system disorders: Hypersensitivity (eg, rash, urticaria, dyspnea, erythema multiforme), anaphylactic reaction (eg, urticaria, angioedema, edema, face edema, shock) General disorders and administration site conditions: Extensive swelling of injected limb (eg, swelling that involves adjacent joints) Nervous system: Seizure, febrile seizure, hypotonic hyporesponsive episode Contraindications Hypersensitivity to any ingredient of Vaxelis, or any other diphtheria toxoid, tetanus toxoid, pertussis-containing vaccine, inactivated poliovirus vaccine, hepatitis B vaccine, or H influenzae type b vaccine History of encephalopathy (eg, coma, decreased level of consciousness, prolonged seizures) within 7 days of a previous dose of a pertussis-containing vaccine History of progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy, until a treatment regimen is established and condition has stabilized Cautions Epinephrine HCl solution (1:1,000) and other appropriate agents and equipment must be available for immediate use in case an anaphylactic or acute hypersensitivity reaction occurs Patients who develop Guillain-Barre syndrome (GBS) within 6 weeks of receipt of a vaccine containing tetanus-toxoid should not receive any further doses; patients who develop GBS >6 weeks after immunization may receive subsequent doses of the vaccine If administered to immunocompromised persons, including persons receiving immunosuppressive therapy, the expected immune response may not be obtained Apnea following IM vaccination observed in some infants born prematurely; decision about when to administer an IM vaccine to an infant born prematurely should be based on consideration of the infant’s medical status and potential benefits and possible risks of vaccination Vaccination may not protect all individuals Sensitive tests (eg, latex agglutination kits) detected vaccine-derived polyribosylribitol phosphate (PRP) in the urine of vaccinees for ≥30 days following vaccination with Haemophilus b conjugate vaccine; urine antigen detection may not have definite diagnostic value in suspected H influenzae type b disease following vaccination Adverse reactions following prior pertussis vaccination If any of the following events occur after administration of a pertussis vaccine, carefully consider use of Vaxelis Temperature ≥40.5°C (≥105°F) within 48 hr, not attributable to another identifiable cause Collapse or shocklike state (hypotonic-hyporesponsive episode) within 48 hr Persistent, inconsolable crying lasting ≥3 hr within 48 hr Seizures with or without fever within 3 days Pregnancy Not approved for use in individuals ≥5 years No human or animal data are available to assess vaccine-associated risks in pregnancy Lactation Not approved for use in individuals ≥5 years No human or animal data are available to assess the impact on milk production, its presence in breast milk, or its effects on the breastfed infantPregnancy Categories A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk. B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available. Mechanism of Action Conveys active immunity via stimulation of endogenously produced antibodies to diphtheria, tetanus, pertussis, poliovirus, hepatitis B, and Haemophilus influenzae type B IM Administration Before use, shake vial until a uniform, white, cloudy suspension results Visually inspect vial for particulate matter and discoloration prior to administration Withdraw and administer a single 0.5-mL IM dose Infants <1 year: Preferred site of injection is anterolateral aspect of the thigh; do not inject into gluteal area Do not mixed with any other vaccine Storage Vials: Store at 2-8°C (36-46°F); do not freeze No images available for this drug. No images available for this drug.A Patient Handout is not currently available for this monograph.Print FormularyPatient DiscountsAdding plans allows you to compare formulary status to other drugs in the same class.To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.Create Your List of PlansAdding plans allows you to:View the formulary and any restrictions for each plan.Manage and view all your plans together – even plans in different states.Compare formulary status to other drugs in the same class.Access your plan list on any device – mobile or desktop. The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information. View explanations for tiers and restrictions Tier Description 1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs. 2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs. 3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs. 4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products. 5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products. 6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products. NC NOT COVERED – Drugs that are not covered by the plan. Code Definition PA Prior Authorization Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription. QL Quantity Limits Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered. ST Step Therapy Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription. 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