What is a biologic drug (biologics)?
- A biologic drug (biologics) is a product that is produced from living organisms or contain
components of living organisms. - Biologic drugs include a wide variety of
products derived from human, animal, or microorganisms by using biotechnology. - Types of biologic drugs include vaccines, blood, blood components, cells, allergens, genes,
tissues, and recombinant proteins. - Biologic products may contain proteins that
control the action of other proteins and cellular processes, genes that control
production of vital proteins, modified human hormones, or cells that produce
substances that suppress or activate components of the immune system. - Biologic drugs are sometimes referred to as biologic response modifiers because they
change the manner of operation of natural biologic intracellular and cellular
actions.
What are the medical uses for biologics?
Biologic drugs are used for treatment of numerous diseases and conditions, and are
the most advanced therapies available. Some biologic drugs are used for the
treatment of Crohn's disease,
ulcerative colitis, rheumatoid arthritis, and other autoimmune diseases. Available biologics have revolutionized cancer treatment, delayed or
reversed the course of immune related conditions, changed the lives of people
with rare diseases, and have offered hope for many patients who previously had
no effective treatment options for their condition.
Examples of medical uses for biologic drugs include:
- Various cancers
- Rheumatoid arthritis (RA)
- Ankylosing spondylitis
- Crohn's disease
- Ulcerative colitis
- Psoriasis
- Diabetes
- Multiple sclerosis (MS)
- Heart attack
- Systemic lupus erythematous
- Age-related macular degeneration
- Diabetic retinopathy
- Prevention of
pneumonia - Anemia
- Chronic migraine
- Hepatitis B
- Hemophilia
- Respiratory syncytial virus (RSV) prophylaxis
- HPV prevention
- Varicella virus vaccine
- Growth hormone deficiency
- Osteoporosis
- Allergic asthma
- Chronic idiopathic urticaria
- Infertility
- Prevention of meningococcal disease
- Cystic fibrosis
- Paroxysmal nocturnal hemoglobinuria
QUESTION
The term arthritis refers to stiffness in the joints.
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What are the side effects of biologics?
Side effects of a biologic drug depends on the specific biologic drug, and method of
introduction into the body.
- Most biologic drugs have the potential to cause
allergic hypersensitivity reactions. - Biologic drugs that are used for rheumatoid
arthritis, psoriasis, and other immune related disorders suppress the immune
system and increase the risk of infections. - Since some biologic drugs are given
by injection they also can cause injection site reactions. - Other biologic drugs
are given intravenously and can cause infusion reactions.
These side effects are compiled from side effects listed for several biologic
drugs. Each type of biologic drug has its own specific side effect profile and
may or may not cause the side effects listed here.
Common side effects of biologic drugs include:
- Allergic reactions
- Injection site
reactions - Chills
- Weakness
- Diarrhea
- Nausea
- Vomiting
- Rash
- Itching
- High blood glucose
levels - Cough
- Constipation
Other side effects of biologic drugs include:
- Shortness of breath
- Peripheral edema
- Headache
- Fever
- Muscle aches and pain
- Decreased appetite
-
Increased
triglyceride levels - Insomnia
- Abdominal pain
- Back pain
- Dizziness
- Infusion reactions
Serious side effects of biologic drugs include:
- Low blood pressure
- Anaphylaxis
- Serious infections
- Cancer
- Serum sickness
-
Autoimmune
thyroiditis -
Arterial and venous
blood clots - Congestive heart
failure - Bleeding
- Interstitial lung
disease - Hepatitis
- Generation of
antibodies - Enterocolitis
- Gastrointestinal
perforation - Mucositis
- Stomatitis
- Anemia
- Reduced white blood
cell counts - Hypothyroidism
What preparations are available for biologics?
Biologic drugs are administered by injection or infusion because they are
proteins that are quickly digested and inactivated if given by mouth. Therefore,
biologic drugs are supplied as powders for infusion or solutions for injection.
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Which drugs or supplements interact with biologics?
- Biologic drugs, for example, adalimubab (Humira), that affect the immune system may interfere
with the effectiveness of vaccines. Live vaccines, including attenuated
vaccines, should not be used while patients are being treated with biologics
that affect the immune system. Patients should complete all recommended
immunizations prior to receiving these types of biologic drygs. Prescreening for
dormant tuberculosis (TB) generally
is recommended. - Serious infections are more likely to occur when biologic drugs that suppress the
immune system are combined with other drugs that also suppress the immune
system.
Are biologics safe to use during pregnancy or while breastfeeding?
- Most biologic drugs have not been adequately studied in
pregnant women or women
who are breastfeeding. - Some biologics, for example follitropin alpha (Gonal f),
nivolumab (Opdivo), and pembrolizumab (Keytruda), may be harmful to the fetus
because of their mechanism of action and the results from animal studies. - Some
biologic drygs may be present in breast milk. Mothers who are breastfeeding should
decide with their doctors whether or not to stop or discontinue the biologic
because many drugs are excreted in breast milk and there may present a risk of
serious adverse effects in the infant.
What brand and generic names are available for biologics?
List of examples of brand and generic biologic drugs available in the US
- abatacept (Orencia)
- abciximab (ReoPro)
- abobotulinumtoxinA (Dysport)
- adalimumab (Humira)
- adalimumab-atto (Amjevita)
- ado-trastuzumab emtansine (Kadcyla)
- aflibercept (Eylea)
- agalsidase beta (Fabrazyme)
- albiglutide (Tanzeum)
- aldesleukin (Proleukin)
- alemtuzumab (Campath, Lemtrada)
- alglucosidase alfa (Myozyme, Lumizyme)
- alirocumab (Praluent)
- alteplase, cathflo activase (Activase)
- anakinra (Kineret)
- asfotase alfa (Strensiq)
- asparaginase (Elspar)
- asparaginase erwinia chrysanthemi (Erwinaze)
- atezolizumab (Tecentriq)
- basiliximab (Simulect)
- becaplermin (Regranex)
- belatacept (Nulojix)
- belimumab (Benlysta)
- bevacizumab (Avastin)
- bezlotoxumab (Zinplava)
- blinatumomab (Blincyto)
- brentuximab vedotin (Adcetris)
- canakinumab (Ilaris)
- capromab pendetide (ProstaScint)
- certolizumab pegol (Cimzia)
- cetuximab (Erbitux)
- collagenase (Santyl)
- collagenase clostridium histolyticum (Xiaflex)
- daclizumab (Zenapax)
- daclizumab (Zinbryta)
- daratumumab (Darzalex)
- darbepoetin alfa (Aranesp)
- denileukin diftitox (Ontak)
- denosumab (Prolia, Xgeva)
- dinutuximab (Unituxin)
- dornase alfa (Pulmozyme)
- dulaglutide (Trulicity)
- ecallantide (Kalbitor)
- eculizumab (Soliris)
- elosulfase alfa (Vimizim)
- elotuzumab (Empliciti)
- epoetin alfa (Epogen/Procrit)
- etanercept (Enbrel)
- etanercept-szzs (Erelzi)
- evolocumab (Repatha)
- filgrastim (Neupogen)
- filgrastim-sndz (Zarxio)
- follitropin alpha (Gonal f)
- galsulfase (Naglazyme)
- glucarpidase (Voraxaze)
- golimumab (Simponi)
- golimumab injection (Simponi Aria)
- ibritumomab tiuxetan (Zevalin)
- idarucizumab (Praxbind)
- idursulfase (Elaprase)
- incobotulinumtoxinA (Xeomin)
- infliximab (Remicade)
- infliximab-dyyb (Inflectra)
- interferon alfa-2b (Intron A)
- interferon alfa-n3 (Alferon N Injection)
- interferon beta-1a (Avonex, Rebif)
- interferon beta-1b (Betaseron, Extavia)
- interferon gamma-1b (Actimmune)
- ipilimumab (Yervoy)
- ixekizumab (Taltz)
- laronidase (Aldurazyme)
- mepolizumab (Nucala)
- methoxy polyethylene glycol-epoetin beta (Mircera)
- metreleptin (Myalept)
- natalizumab (Tysabri)
- necitumumab (Portrazza)
- nivolumab (Opdivo)
- obiltoxaximab (Anthim)
- obinutuzumab (Gazyva)
- ocriplasmin (Jetrea)
- ofatumumab (Arzerra)
- olaratumab (Lartruvo)
- omalizumab (Xolair)
- onabotulinumtoxinA (Botox)
- oprelvekin (Neumega)
- palifermin (Kepivance)
- palivizumab (Synagis)
- panitumumab (Vectibix)
- parathyroid hormone (Natpara)
- pegaspargase (Oncaspar)
- pegfilgrastim (Neulasta)
- peginterferon alfa-2a (Pegasys)
- peginterferon alfa-2b (PegIntron, Sylatron)
- peginterferon beta-1a (Plegridy)
- pegloticase (Krystexxa)
- pembrolizumab (Keytruda)
- pertuzumab (Perjeta)
- ramucirumab (Cyramza)
- ranibizumab (Lucentis)
- rasburicase (Elitek)
- raxibacumab
- reslizumab (Cinqair)
- reteplase (Retavase)
- rilonacept (Arcalyst)
- rimabotulinumtoxinB (Myobloc)
- rituximab (Rituxan)
- romiplostim (Nplate)
- sargramostim (Leukine)
- sebelipase alfa (Kanuma)
- secukinumab (Cosentyx)
- siltuximab (Sylvant)
- tbo-filgrastim (Granix)
- tenecteplase (TNKase)
- tocilizumab (Actemra)
- trastuzumab (Herceptin)
- ustekinumab (Stelara)
- vedolizumab (Entyvio)
- ziv-aflibercept (Zaltrap)