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  • Humira binds to TNF molecules and blocks them. By blocking the TNF molecules, adalimumab lowers swelling and pain. It reduces symptoms and the damage caused by those inflammatory conditions. - Source: Internet
  • ERA is an inflammatory disease of the joints and the places where tendons join the bone. Humira is used to treat ERA in children. You may have already been given other medicines to treat your condition. Your doctor has prescribed Humira for you as you haven’t responded well enough to these medicines. Psoriatic arthritis (PsA) - Source: Internet
  • As Humira was one of the earlier biologics in a relatively new space, AbbVie was able to patent novel uses for the biologic, said the lawyer. Each time a new feature, indication or method of manufacturing was developed, AbbVie spent resources patenting it, said Brougher. It is unlikely for a patent thicket of this scale to be built for each product by other companies, said Nelson. However, after seeing the wide patentisation of anything around Humira, it would be unsurprising if the United States Patent and Trademark Office (USPTO) applies the novelty test more vigorously, said the lawyer. - Source: Internet
  • Liver Problems. Liver problems can happen in people who use TNF-blocker medicines. These problems can lead to liver failure and death. Call your doctor right away if you have any of these symptoms: - Source: Internet
  • In patients with early aggressive rheumatoid arthritis, adalimumab produces similar results as methotrexate after one year of therapy. 6 When used alone in early aggressive rheumatoid arthritis, adalimumab therapy can be expected to result in 23 percent of patients achieving remission and 41 percent of patients exhibiting clinical response after one year. 6 However, when combined with methotrexate, the remission rates nearly double (43 percent) and response rates increase significantly (62 percent). 6 After two years of combined therapy, benefit should still be evident, with close to one half of patients achieving remission, whereas only one fourth of patients on single-agent therapy will achieve remission. 6 - Source: Internet
  • “The European patents will expire in October 2018, opening the door to biosimilars on the European market,” says Gilmore. “In the US, the patent exclusivity runs to 21 January 2023 so Humira biosimilars from Amgen (Abjevita) and Samsung Bioepis (Imraldi) will not hit this market until then. In Europe, when the patents for biologics Enbrel and Remicade expired, there was a resulting decrease of 10%-15% in the cost of therapy, a trend which Humira will likely mirror.” - Source: Internet
  • Humira lost its patent protection in autumn 2018. At the end of the patent protection, competition from various manufacturers began, which caused prices to drop. According to data from the GKV drug index 2016, Humira was actually the drug with the highest sales. Now there are several approved successor products with the same active ingredient (generics) on the market. - Source: Internet
  • What Happens If I Overdose on Humira? If you think you or someone else may have overdosed on Humira, call a healthcare provider or the Poison Control Center (1-800-222-1222). If someone collapses or isn’t breathing after taking Humira, call 911 immediately. 911 - Source: Internet
  • It is becoming even more difficult for people who require a high dosage of the drug. It is also worth noting that other biosimilars are usually 15-30% less expensive than Humira. Despite this fact, people still prefer to use Humira because of its certified results. - Source: Internet
  • Do not reuse needles or syringes. Instead, throw used needles or syringes in a sharps (needle) container and get rid of full containers based on your local guidelines. If you have any questions, ask your healthcare provider or pharmacist. - Source: Internet
  • Humira is used in a variety of strengths, depending on the dosage. A single-dose vial of 40 mg in a 0.8 ml strength solution is available. Prefilled single-dose syringes can be found in the following strengths: - Source: Internet
  • Allergic reactions. Allergic reactions can happen in people who use Humira. Call your doctor or get medical help right away if you have any of these symptoms of a serious allergic reaction: - Source: Internet
  • Humira can help to slow down structural damage caused by the body’s immune system. In addition, it improves the physical functions of the body by introducing a clinical response. You can take the drug alone or in combination with other non-biological Disease-modifying Antirheumatic Drugs (DMARDs) like methotrexate. - Source: Internet
  • Humira (adalimumab) is an injectable drug used to treat Crohn’s disease, plaque psoriasis, ulcerative colitis, and some types of arthritis. It also treats uveitis, and a skin problem called hidradenitis suppurativa. You can get Humira in prefilled syringes, prefilled pens, and vials. - Source: Internet
  • AbbVie has also received criticism for steep price increases and it is not uncommon for drug companies to increase prices of drugs bi-annually. Typically in January and June of each calendar year, AbbVie has increased the price of Humira by an average of 7%-10%, says Gilmore: “Since the price of the drug was high to begin with, the added increases are definitely a burden to both patients and insurance providers. Patient ‘assistance programmes’ are limited in the US, so it has been reported that compliance is suffering as patients skip doses they cannot afford. Phase III clinical trials are extremely expensive though so in many respects with the evolution of the lifecycle and added indications, there is some justification for the price increases for Humira.” - Source: Internet
  • Since 2008, adalimumab had been approved by the FDA for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, moderate to severe chronic psoriasis and juvenile idiopathic arthritis. Although only approved for ulcerative colitis from late 2012, by the FDA in the disease’s management, it had been used for several years in cases that have not responded to conventional treatment at standard dosing for Crohn’s disease.[citation needed] - Source: Internet
  • Psoriasis is an inflammatory disease of the skin. Plaque psoriasis, the most common form, is a skin condition that causes red, flaky, crusty patches of the skin covered with silvery scales. Plaque psoriasis can also affect nails, causing them to crumble, thicken and lift away from the nail bed which can be painful. Humira is used to treat moderate to severe forms of the disease in adults and severe forms in adolescents and children from 4 years of age for whom topical therapy (such as creams, lotions and ointments) and phototherapy (also known as light therapy) have either not worked very well or are not suitable. - Source: Internet
  • Conventional medications also work by suppressing the immune system (immunosuppressants), but in a less targeted and much broader way. They have the great advantage that they have been used for a long time so there is a great wealth of experience regarding their use and side effects. The disadvantage is often their limited effectiveness. - Source: Internet
  • Humira is a so-called monoclonal antibody and, like any effective drug, has side effects. Antibodies can bind certain structures in the body in a targeted way. Mostly these are immune system structures, to suppress the body’s immune response. Humira was initially approved for the treatment of rheumatoid arthritis and is now used for a wide variety of chronic inflammatory diseases. For therapy for inflammatory bowel disease Crohn’s disease and ulcerative colitis, approval represented a major innovation, particularly for those patients for whom well-known medications had little or no success. - Source: Internet
  • If you’re on Humira and living in the States, make sure you talk with your GI and specialty pharmacy to ensure your script is changed to “Citrate-free”. The extra leg work will be so worth it. It brings me so much happiness to know that young children on Humira will never have to feel the pain. It gives me peace of mind as a chronic illness patient to know that developments like this in treatment are possible and happening right now. - Source: Internet
  • Psoriasis is an inflammatory disease of the skin. Plaque psoriasis, the most common form, is a skin condition that causes red, flaky, crusty patches of the skin covered with silvery scales. Plaque psoriasis can also affect nails, causing them to crumble, thicken and lift away from the nail bed which can be painful. Humira is used to treat moderate to severe forms of the disease in adults and severe forms in adolescents and children from 4 years of age for whom topical therapy (such as creams, lotions and ointments) and phototherapy (also known as light therapy) have either not worked very well or are not suitable. Hidradenitis suppurativa (HS) - Source: Internet
  • Crohn’s disease is an inflammatory disease of the digestive tract. Humira is used to treat moderate to severe Crohn’s disease, in adults and children aged 6 years and over, to reduce the signs and symptoms of the disease and to induce and maintain periods where the symptoms are no longer present (remission). You may have already been given other medicines to treat your condition. Your doctor has prescribed Humira for you as you may either have not responded well enough, or you may have lost response or cannot tolerate these medicines. Ulcerative Colitis - Source: Internet
  • Fact In April and May 2017, AbbVie spent just shy of $50 million in Humira advertisements. The drug maker reserved eight spots in May alone: two for arthritis , four for ulcerative colitis and Crohn’s, and two for psoriasis. The biggest-ticket ad was “Volunteering,” a $10.9 million ad for arthritis. Source: FiercePharma - Source: Internet
  • The cost of Humira has more than doubled between the years 2012 and 2018. As a result, many consumers cannot afford it even with coupons, rebates, and government intervention. Many Canadian employers, on the other hand, have agreed to cover the expenses. - Source: Internet
  • While Humira’s primary patent was set to expire in 2018, it now expires in 2034. An early entry in 2023 would be open to only those biosimilar manufacturers with which AbbVie has had individual settlements. Others would get an approval and launch at risk or pursue their own settlements. Any subsequent patents gained on Humira extending its exclusivity should likely not affect the entry date of those biosimilars, experts said. - Source: Internet
  • This is the most critical part of the whole process. You have to hold the Humira pen at a 90-degree angle while you are injecting it. You can then firmly and gradually press the needle into your skin. - Source: Internet
  • Ulcerative colitis is an inflammatory disease of the large intestine (bowel). Humira is used to treat moderate to severe ulcerative colitis when other medicines are not appropriate. Psoriasis - Source: Internet
  • pJIA is an inflammatory disease of the joints. Humira is used to reduce the signs and symptoms of moderate to severely active pJIA, in patients 2 years of age and older, when other medicines are not appropriate. Your doctor will decide whether Humira should be used with another medicine called methotrexate or used alone. Enthesitis-related arthritis (ERA) - Source: Internet
  • To understand which side effects can be caused by therapeutic antibodies like Humira, you should keep the mode of action in mind. The target of the active substance adalimumab, which is contained in Humira, is the so-called tumor necrosis factor (short: TNF-α). It is a messenger for our immune system - which is widespread and effective: it affects almost all cells and is an essential mediator of immune and inflammatory reactions. - Source: Internet
  • Adalimumab, sold under the brand name Humira, among others, is a monoclonal antibody used to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, uveitis, and juvenile idiopathic arthritis.[24][25][26] It is administered by injection under the skin.[24] - Source: Internet
  • Ankylosing spondylitis is an inflammatory disease of the spine. Signs and symptoms of ankylosing spondylitis include back pain and stiffness. Humira is used to reduce the signs and symptoms in patients with active disease. Crohn’s Disease - Source: Internet
  • Adalimumab used alone offers little benefit over the traditional first-line agent, methotrexate. However, it increases remission rates when combined with methotrexate in early aggressive rheumatoid arthritis and when combined with traditional DMARDs in those who have not derived benefit from existing regimens. Most patients experience few side effects; however, rare, serious adverse events can occur. - Source: Internet
  • It is important that you put your used needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or health care provider to get one. - Source: Internet
  • Ankylosing spondylitis is an inflammatory disease of the spine. Signs and symptoms of ankylosing spondylitis include back pain and stiffness. Humira is used to reduce the signs and symptoms in patients with active disease. - Source: Internet
  • Adalimumab has been shown to treat moderate to severe chronic plaque psoriasis in adults who have the condition in many areas of their body and who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light alone or with pills).[43] Adalimumab has been shown to be effective therapy when used either continuously or intermittently in patients with moderate to severe psoriasis.[44] - Source: Internet
  • With your finger, push on the trigger, which you will find at the top of your Humira pen. You will hear a ‘click’ when the injection starts. Keep holding the pen in place as you are injecting the medicine. - Source: Internet
  • However, whether individual settlements keep the door open for other manufactures to launch early remains to be seen, said Blais. The 2023 launch of biosimilars may impact AbbVie’s ability to obtain an injunction against a new company with the intention to market a biosimilar, said Nelson. Previously, in a case involving Amgen ’s biosimilar version of Roche ’s Herceptin (trastuzumab), a district court denied preliminary injunctive relief based on Roche’s pattern and practice of granting licenses for Herceptin’s dosing patents. The fact Roche allowed other biosimilar manufactures to enter the market through individual settlements undermined its assertion of “irreparable harm” by Amgen’s biosimilar launch. Based on this, biosimilar manufacturers could even argue there is no irreparable harm because AbbVie was willing to license Humira to others it settled with, which could lead to an earlier entry than 2023, said Blais. - Source: Internet
  • Uveitis is an inflammatory disease affecting certain parts of the eye.This inflammation may lead to a decrease of vision and/or the presence of floaters in the eye (black dots or wispy lines that move across the field of vision). Humira is used to treat non-infectious intermediate, posterior and pan-uveitis. - Source: Internet
  • Before using Humira, take it out of the fridge and leave it at room temperature for 15–30 minutes. This helps make the injection less painful. Do not heat it up or remove the cap or cover while waiting for your medication to reach room temperature. The needle cover for the pen and the cap of the prefilled syringe may contain latex. - Source: Internet
  • Once the window on your pen fills with a yellow marker or appears to be empty, you can remove the injection. First, you have to discard the syringe in a designated trash bin. Then place a sterilized cotton ball over the injection site. - Source: Internet
  • PsA is an inflammatory disease of the joints that is usually associated with psoriasis. Signs and symptoms include joint pain, tenderness and swelling. Humira is used to reduce the signs and symptoms, of moderate to severely active PsA, as well as to slow down and protect the joints from further damage, to help them move more freely. - Source: Internet
  • Gilmore believes the drug will be less expensive in the European Union from October 2018 when biosimilars become available: “At least part of the world will be able to continue using the drug with fewer burdens. The US does not have reference drug pricing like they do in Europe and Japan. In other regions of the world, the initial drug price is set by the government. In Japan, companies are required to lower the cost of the drug every other year.” - Source: Internet
  • Lift the pen straight up from the injection site. The white needle sleeve will move down over the needle and lock into place over the needle tip. Do not try to touch the needle. The white needle sleeve is there to protect you from touching the needle (see Figure 6) - Source: Internet
  • “Drugwatch opened my eyes to the realities of big pharmacy. Having a family member with major depression and anxiety, I was looking for information on her medications. I found information that was very helpful, that her psychiatrist never told her.” - Source: Internet
  • Medications such as Humira are specialty drugs with a high treatment cost. For example, Humira is currently available in Canada for about $800. This is one of the most expensive drugs in Canada and worldwide, even though it is quite common. - Source: Internet
  • You might get infections more easily while you are receiving Humira treatment. These infections may be serious and include tuberculosis, infections caused by viruses, fungi, parasites or bacteria, or other infections. Sepsis, an infection of the blood, may, in rare cases, be life-threatening. - Source: Internet
  • The US Food and Drug Administration (FDA) authorized the use of Humira in treating rheumatoid arthritis on December 31, 2002. It is also used in several gastrointestinal, spinal, and skin disorders. As a result, this drug has been authorized to treat approximately 10 conditions in Canada and 14 in other parts of the world. - Source: Internet
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