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Adalimumab is an antibody that captures the inflammatory messenger TNF-alpha and is used for rheumatoid arthritis, ankylosing spondylitis, psoriasis and inflammatory bowel disease. It is usually injected under the skin every two weeks with a pre-filled pen. Because it dampens parts of the immune defence, tuberculosis and hepatitis tests before the start, a watchful eye on infections and a well-planned vaccination schedule are all part of the treatment.
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According to the SmPC, people on adalimumab may be vaccinated — with the exception of live vaccines.¹ The STIKO (Standing Committee on Vaccination at the Robert Koch Institute) recommends additional vaccinations for patients on immunomodulating treatment, because infections can be more severe in them. Ideally, vaccination status is completed before treatment starts, because the vaccine response can be weaker during treatment.⁴
| Vaccination | On adalimumab | Note |
|---|---|---|
| Flu (influenza) | Possible and recommended | Every year in autumn |
| Pneumococcal | Possible and recommended | Schedule according to the current STIKO recommendation |
| COVID-19 | Possible | Boosters according to the current STIKO recommendation |
| Shingles (inactivated vaccine) | Possible | The inactivated vaccine is not a live vaccine; the STIKO sets the age from which it is recommended for people at increased risk |
| Tetanus, diphtheria, whooping cough, hepatitis B and other inactivated vaccines | Possible | Continue boosters as usual |
| Measles, mumps and rubella (MMR), chickenpox, yellow fever | Not during treatment | Live vaccines; if needed, before the start, with a sufficient interval |
More on this topic in the guide Vaccines and medications and under Vaccinations for adults.
Since Humira's patent expired, numerous biosimilars have come onto the market — biotechnologically produced follow-on products with the same active ingredient. Unlike chemical generics, biologics are never identical down to the last molecule; for approval, however, biosimilars must show in extensive comparative studies that they are equivalent in quality, efficacy and safety. In 2022, the European Medicines Agency and the heads of the national medicines agencies jointly stated that biosimilars approved in the EU are interchangeable with their reference product and with one another.⁵ The background is explained in the guide Understanding biosimilars.
Since 1 April 2026, Germany has had a substitution rule for biologics that patients use themselves (§ 40c of the Arzneimittel-Richtlinie, the pharmaceuticals directive of the G-BA, the Federal Joint Committee that decides on statutory health insurance benefits). Pharmacies then substitute a prescribed adalimumab product with a discounted or cheaper one if, among other things, at least one indication matches, the strength and pack size are identical and the container is the same too — so a pen is only exchanged for a pen, and a pre-filled syringe for a pre-filled syringe. For medical reasons, the practice can rule out substitution in an individual case by ticking “aut idem” on the prescription (the box that excludes substitution); the pharmacy can also refrain from substituting if it has justified concerns.⁶
To be honest: many patients feel unsure about the first switch, and some report subjectively that it works less well or stings more. Studies show no differences in efficacy and safety for approved biosimilars; even so, it is worth not brushing changes aside but noting them with the date and raising them. More on the difference between the original and follow-on products in the guide Generics vs. brand-name medicines.
As an antibody, adalimumab is not broken down by the liver enzymes that cause most interactions with tablets. What matters most are combinations that weaken the immune defence even further.¹
| Combination | Consequence | What to do |
|---|---|---|
| Methotrexate | Fewer antibodies against adalimumab, better effect in rheumatoid arthritis | Intended combination; monitoring for both medicines |
| Anakinra, abatacept, other TNF-alpha inhibitors or biologics | More serious infections without additional benefit | According to the SmPC, not recommended |
| Azathioprine or 6-mercaptopurine | Rare, aggressive lymphoma described in young adults with bowel disease | Combination only after careful consideration |
| Cortisone, e.g. prednisolone | Additionally increased risk of infection | Reduce cortisone according to plan; see Stopping cortisone |
| Live vaccines | Vaccine viruses can cause illness | Do not give during treatment |
| Alcohol | No direct interaction; with methotrexate, additional strain on the liver | Restraint; see Medications and alcohol |
The real interaction is an organisational one. Adalimumab does not appear on many medication plans because it is only injected every two weeks. The GP practice, dentist, emergency department or vaccination centre often know nothing about it — with consequences for assessing an infection or choosing a vaccine. So add the injection to your digital medication plan and check new prescriptions with the interaction check.
The specialist societies summarise the checks in therapy information sheets; your practice sets the exact schedule.²
| Check | When | Why |
|---|---|---|
| Tuberculosis test, hepatitis B serology | Before the start; again if there is a new risk | Detect dormant infections before the start |
| Blood count | Before the start and regularly, more often at first | Detect drops in blood cells |
| Liver values | Before the start and regularly, especially with methotrexate | Raised liver values are common |
| Skin check | Before the start and regularly, usually once a year | Non-melanoma skin cancer is more common on TNF-alpha inhibitors |
| Colonoscopy | In long-standing ulcerative colitis, according to the screening schedule | Detect early changes in the lining of the bowel |
| Vaccination status | Before the start and once a year | Close gaps, plan boosters |
Sun protection is particularly important on TNF-alpha inhibitors — see Medications and sun and the article on non-melanoma skin cancer. How to interpret your results is explained in Understanding blood values.
According to the SmPC, women of childbearing age should consider reliable contraception and continue it until at least five months after the last injection. Data from around 2,100 pregnancies show no increased rate of birth defects; in pregnancy, adalimumab should nevertheless only be used if it is clearly needed, because it crosses the placenta to the baby. According to the SmPC, breastfeeding is possible, as only very small amounts pass into breast milk.¹ Embryotox counts adalimumab among the TNF-alpha inhibitors for which there is a lot of experience; active underlying disease during pregnancy is often riskier than the medicine.⁷ Plan early with your practice — and also read Medications during pregnancy.
Because of the long half-life, the SmPC says that before planned operations, it should be taken into account when the last injection was given; after the procedure, particular attention is paid to infections. Whether and for how long to pause beforehand is agreed between the operating and the prescribing practice — according to the SmPC, after an interruption of 70 days or more, adalimumab worked about as well as before when restarted in rheumatoid arthritis.¹ See Medications before surgery.
In moderate to severe heart failure (NYHA III/IV), adalimumab must not be used according to the SmPC, and in mild heart failure only with caution. New or increasing shortness of breath and fluid retention are a reason for prompt assessment.¹
With an existing or recently occurring demyelinating disease such as multiple sclerosis, the SmPC calls for particular caution. In certain forms of uveitis, a neurological examination is carried out before the start.
From the age of 65, serious infections occur more often, according to the SmPC. After cancer, the decision is weighed up particularly carefully, because there are hardly any study data for this situation. In COPD and heavy smoking, the SmPC also advises caution.¹
With a mild cold without fever, injections often continue; with fever, feeling clearly unwell or an infection that needs antibiotics, they are often postponed. The decision is made by your practice — before the injection, not afterwards. A short call with three details helps: since when, how high the fever is, which symptoms. Afterwards, note when you gave the postponed injection so that the rhythm is right again.
Same active ingredient, yes: since April 2026, pharmacies have been substituting biologics with an interchangeable product under fixed conditions. However, the pen may work differently, and the storage time outside the fridge may differ. Ask to be shown how to use it and take the new manufacturer's patient card with you. If, for medical reasons, you should stay on your previous product, that is a decision for your practice, which notes it on the prescription.
More respiratory infections are the most common side effect. The vaccinations from section 7, hand hygiene during cold season and an honest look at other factors such as cortisone can help. Keep a record of how often and for how long you are ill. If the frequency or severity increases markedly, that belongs in a conversation: sometimes cortisone can be reduced further or the interval adjusted. The decision lies with the treating practice.
Not on your own. According to the package leaflet, your symptoms can return if you stop adalimumab. In some conditions, extending the interval or reducing the dose is discussed during stable remission — that is a planned step with check-ups, not a spontaneous stop. Bring your history to the appointment: how long have you been symptom-free, and what were your inflammation markers?
A digital medication plan also shows the injection that is only due every two weeks — along with the product and vaccinations.
