Recombivax

Side Effects
Interactions

SIDE EFFECTS

In healthy infants and children (up to 10 years of age), the most frequently reported systemic adverse reactions ( > 1% injections), in decreasing order of frequency, were irritability, fever, diarrhea, fatigue/weakness, diminished appetite, and rhinitis. In healthy adults, injection site reactions and systemic adverse reactions were reported following 17% and 15% of the injections, respectively.

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine and may not reflect the rates observed in practice.

In three clinical studies, 434 doses of RECOMBIVAX HB, 5 mcg, were administered to 147 healthy infants and children (up to 10 years of age) who were monitored for 5 days after each dose. Injection site reactions and systemic adverse reactions were reported following 0.2% and 10.4% of the injections, respectively. The most frequently reported systemic adverse reactions ( > 1% injections), in decreasing order of frequency, were irritability, fever ( ≥ 101°F oral equivalent), diarrhea, fatigue/weakness, diminished appetite, and rhinitis.

In a study that compared the three-dose regimen (5 mcg) with the two-dose regimen (10 mcg) of RECOMBIVAX HB in adolescents, the overall frequency of adverse reactions was generally similar.

In a group of studies, 3258 doses of RECOMBIVAX HB, 10 mcg, were administered to 1252 healthy adults who were monitored for 5 days after each dose. Injection site reactions and systemic adverse reactions were reported following 17% and 15% of the injections, respectively. The following adverse reactions were reported:

Incidence Equal To or Greater Than 1% of Injections

General Disorders And Administration Site Conditions

Injection site reactions consisting principally of soreness, and including pain, tenderness, pruritus, erythema, ecchymosis, swelling, warmth, nodule formation.

The most frequent systemic complaints include fatigue/weakness; headache; fever ( ≥ 100°F); malaise.

Gastrointestinal Disorders

Nausea; diarrhea

Respiratory, Thoracic And Mediastinal Disorders

Pharyngitis; upper respiratory infection

Incidence Less Than 1% of Injections

General Disorders And Administration Site Conditions

Sweating; achiness; sensation of warmth; lightheadedness; chills; flushing

Gastrointestinal Disorders

Vomiting; abdominal pains/cramps; dyspepsia; diminished appetite

Respiratory, Thoracic And Mediastinal Disorders

Rhinitis; influenza; cough

Nervous System Disorders

Vertigo/dizziness; paresthesia

Skin And Subcutaneous Tissue Disorders

Pruritus; rash (non-specified); angioedema; urticaria

Musculoskeletal And Connective Tissue Disorders

Arthralgia including monoarticular; myalgia; back pain; neck pain; shoulder pain; neck stiffness

Blood And Lymphatic Disorders

Lymphadenopathy

Psychiatric Disorders

Insomnia/disturbed sleep

Ear And Labyrinth Disorders

Earache

Renal And Urinary Disorders

Dysuria

Cardiac Disorders

Hypotension

Post-Marketing Experience

The following additional adverse reactions have been reported with use of the marketed vaccine. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to a vaccine exposure.

Immune System Disorders

Hypersensitivity reactions including anaphylactic/anaphylactoid reactions, bronchospasm, and urticaria have been reported within the first few hours after vaccination. An apparent hypersensitivity syndrome (serum-sickness-like) of delayed onset has been reported days to weeks after vaccination, including: arthralgia/arthritis (usually transient), fever, and dermatologic reactions such as urticaria, erythema multiforme, ecchymoses and erythema nodosum [see WARNINGS AND PRECAUTIONS]. Autoimmune diseases including systemic lupus erythematosus (SLE), lupus-like syndrome, vasculitis, and polyarteritis nodosa have also been reported.

Gastrointestinal Disorders

Elevation of liver enzymes; constipation

Nervous System Disorders

Guillain-Barré syndrome; multiple sclerosis; exacerbation of multiple sclerosis; myelitis including transverse myelitis; seizure; febrile seizure; peripheral neuropathy including Bell's Palsy; radiculopathy; herpes zoster; migraine; muscle weakness; hypesthesia; encephalitis

Skin and Subcutaneous Disorders

Stevens-Johnson syndrome; alopecia; petechiae; eczema

Musculoskeletal and Connective Tissue Disorders

Arthritis

Pain in extremity

Blood and Lymphatic System Disorders

Increased erythrocyte sedimentation rate; thrombocytopenia

Psychiatric Disorders

Irritability; agitation; somnolence

Eye Disorders

Optic neuritis; tinnitus; conjunctivitis; visual disturbances; uveitis

Cardiac Disorders

Syncope; tachycardia

The following adverse reaction has been reported with another Hepatitis B Vaccine (Recombinant) but not with RECOMBIVAX HB: keratitis.

Read the Recombivax (hepatitis b vaccine (recombinant)) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

Concomitant Administration With Other Vaccines

Do not mix RECOMBIVAX HB with any other vaccine in the same syringe or vial. Use separate injection sites and syringes for each vaccine.

In clinical trials in children, RECOMBIVAX HB was concomitantly administered with one or more of the following US licensed vaccines: Diphtheria, Tetanus and whole cell Pertussis; oral Poliomyelitis vaccine; Measles, Mumps, and Rubella Virus Vaccine, Live; Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)] or a booster dose of Diphtheria, Tetanus, acellular Pertussis. Safety and immunogenicity were similar for concomitantly administered vaccines compared to separately administered vaccines.

In another clinical trial, a related HBsAg-containing product, COMVAX® [Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine], was given concomitantly with eIPV (enhanced inactivated Poliovirus vaccine) or VARIVAX® [Varicella Virus Vaccine Live (Oka/Merck)], using separate sites and syringes for injectable vaccines. No serious vaccine-related adverse events were reported, and no impairment of immune response to these individually tested vaccine antigens was demonstrated.

COMVAX has also been administered concomitantly with the primary series of DTaP to a limited number of infants. No serious vaccine-related adverse events were reported.

Concomitant Administration With Immune Globulin

RECOMBIVAX HB may be administered concomitantly with HBIG. The first dose of RECOMBIVAX HB may be given at the same time as HBIG, but the injections should be administered at different sites.

Read the Recombivax Drug Interactions Center for a complete guide to possible interactions

Last reviewed on RxList: 9/2/2014
This monograph has been modified to include the generic and brand name in many instances.

Side Effects
Interactions
A A A

Recombivax - User Reviews

Recombivax User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Recombivax sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Living Better

Find the secrets to longer life.


NIH talks about Ebola on WebMD