a). Description of Humira
Humira (adalimumab) is a medicine that is used in people with mild to severe rheumatoid arthritis (RA). RA is an inflammatory disease that attacks joints. People with RA are often given other drugs for their disease before they are administered Humira. Humira is for individuals with RA who have not responded well enough to these other medicines. Humira (adalimumab) is a recombinant human IgG1 monoclonal antibody uniquely for human tumor necrosis factor (TNF). Humira was formulated using phage display technology, which resulted in an antibody with human derived heavy and light chain variable regions and human IgG1: k constant regions. Humira is manufactured by recombinant (DNA) technology in a mammalian cell expression system and is purified by a process that includes specific viral inactivation and elimination steps.
It is made up of 1330 amino acids and has a molecular weight of exactly 148 kilodaltons. Humira is supplied in single-use, 1 mL pre-filled glass syringes, and equally 2 mL glass vials as a sterile, preservative-free remedy for subcutaneous administration. The solution of Humira uses is colorless and clear. Each vial contains exactly 0.9 mL of solution to offer 0.8 mL (40 mg) of drug product.
b). Possible side effects of Humira
There are a series of Humira side effects. Therefore, keep your doctor informed of any diseases you are suffering from before attempting to take Humira (adalimumab), most especially chronic infections. Your physician will examine you for (TB) and run a test to see if you have TB. If your doctor finds out that you are at risk for TB, you may be treated with the drug for TB before you start treatment with Humira and during treatment with Humira. Even if your TB test is negative your health care professional should carefully monitor you for TB infections while he is administering Humira. People who had a negative TB skin test before taking Humira have developed active TB. Discuss with your doctor if you have any of the following symptoms while taking or after taking Humira:
- Cough that does not go away
- Low grade fever
- Weight loss
- Loss of body fat and muscle (wasting)
Additionally, Hepatitis B infection in people and people who carry the virus in their bloodstream may get worsens. If you are diagnosed with hepatitis B virus (a virus that affects the liver), the virus can become vibrant while you take Humira. Your doctor may carry out blood tests before you start treatment with Humira and while you are using Humira, inform your doctor if you have any of the following symptoms of a possible hepatitis B infection:
- Muscle aches
- Feel very tired
- Dark urine
- Skin or eyes look yellow
- Little or no appetite
- Clay-colored bowel movements
- Stomach discomfort
- Skin rash
Allergic reactions: Allergic reactions can happen in people who take Humira. Call your doctor or get medical help right away if you have any of these signs of a serious allergic reaction:
- Swelling of your eyes, face, mouth or lips
- Trouble breathing are indicators of side effects Humira
Nervous system problems: The signs and symptoms that may arise due to a nervous system problem include: numbness or tingling, difficulties with your vision, weakness in your arms or legs, as well as dizziness all depicts Humira side effects.
Blood problems: Your body may not make enough of the blood cells that assist fight infections or help to stop bleeding. Signs include bruising or bleeding very easily, a fever that does not go away, or looking very pale. Recent heart failure or worsening of heart failure you are suffering from already. Call your physician straight away if you get new worsening signs of heart failure while administering Humira, including:
- Shortness of breath
- Swelling of your ankles or feet
- Sudden weight gain signifies the side effects Humira
Immune reactions, including a lupus-like syndrome: Symptoms include chest pain or discomfort that does not go away, shortness of breath, a rash or joint pain in your arms or cheeks that gets worse in the sun. Symptoms may enhance when you stop Humira.
Liver Problems: Liver problems can occur in people who use TNF-blocker medicines. These problems can result to liver problem and death. Call your doctor straightaway if you have any of these symptoms:
- Feel very weak
- Skin or eyes look yellow
- Poor appetite or vomiting
- Pain on the right side of your stomach (abdomen) are side effects Humira
Psoriasis: A handful of people using Humira had new psoriasis or worsening of psoriasis they already had. Discuss with your doctor if you developed red, scaly patches and/or raised bumps that are filled with pus. Your physician may decide to stop your treatment with Humira. Call your physician or get medical care right away if you develop any of the above signs. Your therapy with Humira may be stopped.
Common side effects of Humira include:
- Injection site reactions: redness, swelling, rash, bruising or itching. These symptoms usually will go away within a few days. Call your physician right away if you have pain, swelling or redness around the injection site that does not go away within a few days or gets worse.
- Upper respiratory infections (including sinus infections) reveal the side effects of Humira
- Ear congestion
- Gas with stomach or abdominal pain
- Light headedness
- Loss of voice
- Lower back or side pain
- Muscle aches and pains
- Nasal congestion
- Rapid and sometimes shallow breathing
- Sunken eyes
- Trouble sleeping
- Warmth on the skin
- Wrinkled skin
- Abnormal discharge or bleeding of the vagina
- Arm, jaw pain or back
- Black, tarry stools
- Bleeding from the nose or gums
- Bloating or swelling of the face, hands, arms, lower legs or feet
- Blood in the stool or change in the bowel
- Bloody or cloudy urine
- Blurred vision
- Broken bones
- Change in size, color, or shape of an existing mole
- Change in skin color are all signals of Humira side effects
With this extensive list of side effects Humira, it is your responsibility to inform your health care professional of any of the above mentioned side effects of Humira. That is, whether the Humira side effects you experience are intense, common or less common, once you notice any of them, do not think otherwise but rather call your doctor immediately.
c). Patients Counseling information about Humira
Advise patients of the potential advantages and risks of Humira.
Inform patients that Humira may lower the ability of their immune system to fight infections. Instruct patients of the significance of contacting their doctor if they develop any symptoms of infection, including invasive fungal infections, tuberculosis, and reactivation of hepatitis B virus infections.
Counsel patients about the danger of malignancies while receiving Humira.
• Allergic reactions
Advise patients to seek immediate medical attention if they witness any symptoms of intense allergic reactions. Advice latex-sensitive patients that the gray needle cap of the 27 gauge Humira Pen and prefilled syringe contains natural rubber latex.
• Other medical conditions
Advise patients to report any signs of recent or worsening medical conditions such as neurological disease, congestive heart failure, cytopenias or autoimmune complications. Patients should be advised to report any signs suggestive of a cytopenia such as bruising, persistent fever or bleeding.
• Instructions on injection technique
Inform patients that the first injection is to be taken under the supervision of a qualified health care specialist. If a caregiver or patient is to take Humira uses, instruct them in injection techniques and evaluate their ability to inject subcutaneously to ensure the proper administration of Humira.
d). Warnings and Precautions of Humira
i). Serious Infections
Patients treated with Humira are at increased risk for developing serious infections involving various organ systems and sites that may lead to hospitalization or death. Opportunistic infections due to mycobacterial, bacterial, viral, invasive fungal, parasitic, or other opportunistic pathogens alongside blastomycosis, coccidioidomycosis, aspergillosis, legionellosis, listeriosis, candidiasis, histoplasmosis, pneumocystosis and tuberculosis have been reported with TNF blockers. Patients have constantly presented with disseminated, and not a localized disease.
ii). Hypersensitivity reactions
Angioneurotic and anaphylaxisedema have been reported following Humira prescription. If an anaphylactic or other fatal allergic reaction happens, immediately discontinue the administration of Humira and institute appropriate treatment. In clinical tests of Humira in adults, allergic reactions (e.g, anaphylactoid reaction, fixed drug reaction, allergic rash, non-specified drug reaction, urticaria) have been observed.
iii). Hepatitis B virus reactivation
Use of TNF blockers, including Humira, may accelerate the risk of reactivation of hepatitis B virus (HBV) in patients who are chronic carriers of this virus. In some cases, HBV reactivation going on in conjunction with TNF blocker therapy has been disastrous. The majority of these reports have happened in patients concomitantly receiving other medications that suppress the immune system, which may equally contribute to HBV reactivation. Assess patients at risk for HBV infection for prior evidence of HBV infection before initiating TNF blocker treatment. Exercise caution in prescribing TNF blockers for patients identified as carriers of HBV. Sufficient data are not available on the efficacy and safety of treating patients who are carriers of HBV with anti-viral therapy in conjunction with TNF blocker therapy to prevent HBV rejuvenation. For those who are carriers of HBV and need treatment with TNF blockers, closely follow up such patients for clinical and laboratory signs of active HBV infection throughout therapy and for several months following termination of treatment. In patients who develop HBV reactivation, desist Humira and initiate strong anti-viral therapy with exact supportive treatment. The safety of resuming TNF blocker treatment after HBV reactivation is controlled and not known. Therefore, exercise caution when considering resumption of Humira therapy in this case and follow up patients closely.
iv). Neurologic reactions
Use of TNF blocking agents, including Humira, has been linked to rare cases of new onset or exacerbation of clinical signs and/or radiographic evidence of central nervous system demyelinating disease, alongside numerous sclerosis (MS) and optic neuritis, and peripheral demyelinating disease, couple with Guillain-Barré syndrome. Show caution in considering the uses of Humira in patients with preexisting or recent-onset central or peripheral nervous system demyelinating complications; discontinuation of Humira should be considered if any of these complications develop. There is a known association between intermediate uveitis and central demyelinating disorders.
vii) Heart Failure
Cases of worsening congestive heart failure (CHF) and recent onset CHF have been reported with TNF blockers. Cases of worsening CHF have also been noticed with Humira. Humira has not been officially studied in patients with CHF; however, in clinical tests of another TNF blocker, a higher dimension of serious CHF-associated adverse reactions were noticed. Exercise caution when using Humira in patients who have heart failure and follow them up carefully.
e). Uses of Humira
i). Rheumatoid arthritis
Humira is used for reducing signs and symptoms, compelling major clinical response, inhibiting the extension of structural damage, and enhancing physical function in adult patients with moderately to severely active rheumatoid arthritis. Humira can be used solely or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs).
ii). Juvenile Idiopathic Arthritis
Humira is used for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and beyond. Humira can be used solely or in combination with methotrexate.
iii). Psoriatic Arthritis
The uses of Humira is indicated for reducing signs and symptoms, inhibiting the extension of structural damage, as well as enhancing physical function in adult patients with active psoriatic arthritis. Humira can be used solely or in combination with non-biologic DMARDs.
iv). Ankylosing Spondylitis
Humira is used for reducing signs and symptoms in adult patients with active ankylosing spondylitis.
v). Adult Crohn’s Disease
Humira is used for reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn’s disease who have had an insufficient response to conventional treatment. Humira is indicated for decreasing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab.
vi). Pediatric Crohn’s Disease
The uses of Humira are indicated for reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active Crohn’s disease who have had an insufficient response to immune modulators or corticosteroids or such as azathioprine, 6-mercaptopurine, or methotrexate.
v). Ulcerative Colitis
Humira is used for inducing and sustaining clinical remission in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to immune suppressants such as corticosteroids, 6-mercaptopurine (6-MP) or azathioprine. The effectiveness of Humira has not been set up in patients who have lost response to or were intolerant to TNF blockers.
vi). Plaque Psoriasis
Humira is used for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic treatments are medically less appropriate. Humira should only be given to patients who will be closely monitored and have regular follow-up visits with a doctor.
vii). Hid adenitis Suppurativa
Humira is used for the treatment of moderate to severe hid adenitis Suppurativa. Uveitis Humira is used for the treatment of non-infectious intermediate, panuveitis and posterior in adult patients.
f). Dosage of Humira
The approved dosage of Humira for adult patients with rheumatoid arthritis is 40 mg administered every other week as a subcutaneous injection.(MTX), salicylates, glucocorticoids, nonsteroidal anti-inflammatory medicines (NSAIDs), analgesics or other DMARDs could be continued during therapy with Humira. Some patients that are not administered concomitant MTX may obtain additional benefit from increasing the dosing frequency of Humira to 40 mg every week. The dosage of Humira is meant for use under the supervision and guidance of a doctor. Patients may self-inject Humira provided their doctor determines that it is appropriate and with medical monitoring, as necessary, after proper training in injection technique. The solution in the syringe and in the vial should be carefully inspected visually for particulate matter and discoloration prior to subcutaneous prescription. If particulates and discolorations are observed, the product should not be taken. The dosage of Humira does not contain preservatives; therefore, unused fractions of medicine remaining from the syringe or vial should be thrown off. Note that the needle cover of the syringe contains dry rubber (latex), which should not be taken by individuals sensitive to this substance.
Patients using the pre-filled syringes should be instructed to inject the full amount in the syringe (0.8 mL), which offers 40 mg of Humira. For institutions and patients using vials, 0.8 mL of solution providing 40 mg of Humira should be stripped off from the vial and administered according to the directions offered in the Patient Information Leaflet. Injection sites should be rotated and injections should never be given in areas where the skin is tender, bruised, hard or red.
g). Dosage forms and strengths of Humira
Injection: 80 mg/0.8 mL of Humira is offered by a single-use pen (Humira Pen), having a 1 mL prefilled glass syringe with a fixed 29 gauge thin wall, ½ inch needle as well as a black needle cover.
Injection: 40 mg/0.8 mL of Humira is offered by a single-use pen (Humira Pen), having a 1 mL prefilled glass syringe with a fixed 27 gauge, ½ inch needle as well as a gray needle cover.
Injection: 40 mg/0.4 mL of Humira is provided by a single-use pen (Humira Pen), having a 1 mL prefilled glass syringe with a fixed 29 gauge thin wall, ½ inch needle as well as a black needle cover.
• Prefilled Syringe
Injection: 80 mg/0.8 mL of Humira is offered by a single-use, 1 mL prefilled glass syringe alongside a fixed 29 gauge thin wall, ½ inch needle as well as a black needle cover.
Injection: 40 mg/0.8 mL of Humira is provided by a single-use, 1 mL prefilled glass syringe alongside a fixed 27 gauge, ½ inch needle as well as gray needle cover.
Injection: 40 mg/0.4 mL of Humira is offered by a single-use, 1 mL prefilled glass syringe alongside a fixed 29 gauge thin wall, ½ inch needle as well as a black needle cover.
h). Overdose of Humira
Doses up to 10 mg/kg have been administered to patients in clinical tests without evidence of dose-limiting toxicities. In case of overdosage, it is approved that the patient be monitored for any signs or symptoms of adverse reactions or effects and appropriate symptomatic treatment instituted immediately.
i). Storage conditions of Humira
Do not use above the expiration date on the container. Humira must be refrigerated at 2-8° C (36-46° F). Do not freeze. Protect the vial or/and pre-filled syringe from disclosure to light. Store in original carton until time of administration.
j). Use in specific populations
i).Pregnancy (risk summary)
Limited clinical data are available from the Humira Pregnancy Registry. Excluding lost-to-monitoring, data from the registry reports a rate of 5.6% for major birth defects with first trimester use of adalimumab in pregnant women with rheumatoid arthritis (RA), and a rate of 7.8% and 5.5% for major birth defects in the disease-matched and non-diseased comparison classes. Adalimumab is actively transferred across the placenta during the third trimester of pregnancy and may affect the immune response in the in-utero exposed toddler. In an embryo-fetal perinatal growth study carried out in cynomolgus monkeys, no fetal disaster or malformations were noticed by intravenous administration of adalimumab during organogenesis and later in gestation, at doses that produced disclosures up to approximately 373 times the maximum approved human dose (MRHD) of 40 mg subcutaneously without methotrexate.
ii). Lactation (risk summary)
Limited data from case reports in the published literature describe the presence of adalimumab in human milk at infant doses of 0.1% to 1% of the maternal serum height. There are no archives of adverse effects of adalimumab on the breastfed infant and no effects on milk production. The health or development and benefits of breastfeeding should be considered along with the mother’s clinical need for Humira and any potential adverse effects on the breastfed child from Humira or from the underlying maternal condition.
iii). Pediatric use
Efficacy and safety of Humira in pediatric patients for uses other than polyarticular juvenile idiopathic arthritis (JIA) and pediatric Crohn’s disease have not been set up. Due to its inhibition of TNFα, Humira taken during pregnancy could affect the immune response in the in utero-exposed infant and newborn. Data from eight babies exposed to Humira uses in utero suggest adalimumab crosses the placenta. The clinical significance of increased adalimumab levels in infants is not known. The safety of administering live or live-attenuated vaccines in exposed infants is not known. Risks and benefits should be considered prior to vaccinating (live or live-attenuated) exposed infants.
iv). Geriatric use
A total of 519 RA patients 65 years of age and beyond, alongside 107 patients 75 years of age and older, received Humira uses in clinical studies RA-I via IV. No general difference in strength was noticed between these patients and younger patients. The frequency of malignancy and serious infection between Humira treated patients over 65 years of age was higher than for those under 65 years of age. Because there is a higher rate of infections and malignancies in the elderly population, use precaution when treating the elderly.
A disclaimer: This article is for the objective to guide you with vital and updated information of the drug Humira. On the contrary, this article must not in any way be given priority over the prescription of your doctor, who is well versed with your health history.