Basic Nintedanib Information

• International Nonproprietary Name (INN): Nintedanib
• Brand names available in Australia: Ofev
• ATC Code: L01XE31
• Forms & dosages: 100 mg and 150 mg capsules
• Manufacturers in Australia: Boehringer Ingelheim
• Registration status in Australia: TGA approved
• OTC / Rx classification: Prescription-only (Rx)

Critical Warnings & Restrictions

When considering nintedanib, safety concerns warrant attention, especially among certain demographics.

High-Risk Groups (Elderly, Pregnancy, Chronic Illness)

For individuals with known hypersensitivity or severe hepatic impairment (Child-Pugh B or C), nintedanib is contraindicated. Elderly patients must approach nintedanib with caution, particularly if they have other chronic conditions. Pregnant women should strictly avoid nintedanib due to its potential teratogenic effects, making effective contraception essential before commencing treatment.

Interaction With Activities (Driving, Workplace Safety Under Australian Law)

It's crucial to be aware that nintedanib can lead to dizziness or gastrointestinal disturbances. These side effects may impair an individual's ability to drive or operate machinery safely. Patients returning to work or engaging in activities that require alertness should consider these effects seriously.

Q&A — “Can I drive after taking it in Australia?”

Q: Can I drive after taking nintedanib? A: It’s advisable to wait until you know how the medication affects you, as dizziness and other side effects could impair your driving ability.

Usage Basics

Understanding how nintedanib is marketed and classified can clarify its role in treatment.

INN, Brand Names Available in Australia

Nintedanib, sold under the brand name **Ofev**, is available in Australia in both 100 mg and 150 mg capsule forms.

This classification allows for standardised usage across various medical applications in treating conditions like idiopathic pulmonary fibrosis.

Legal Classification (TGA-Approved, PBS-Listed)

Nintedanib has been classified as a prescription medicine and received TGA approval since its introduction in the Australian market. Furthermore, it is listed on the PBS, which ensures affordability and accessibility for patients dealing with specific conditions, such as idiopathic pulmonary fibrosis.

Dosing Guide

Appropriate dosing is essential for efficacy and patient safety.

Standard Regimens (PBS Reference Dosing)

For individuals with idiopathic pulmonary fibrosis (IPF), the standard prescribed dosage is 150 mg taken orally twice daily. In cases where gastrointestinal side effects arise, patients may reduce their intake to 100 mg twice daily to manage these adverse reactions.

Adjustments For Comorbidities

Patients presenting with mild hepatic impairment should have their dosing commenced at 100 mg twice daily. However, for those with moderate or severe impairment, nintedanib is not recommended due to safety concerns.

Q&A — “What If I Miss A Dose?”

Q: What do I do if I miss a dose of nintedanib? A: Simply take the next scheduled dose at the regular time, but do not double up if a dose is missed.

Interaction Chart

Understanding potential interactions can help optimise treatment outcomes.

Food and Drinks (Alcohol, Coffee, Australian Diet Context)

It’s advisable for patients to steer clear of alcohol while using nintedanib, as doing so can exacerbate side effects. Additionally, limiting caffeine-rich beverages is recommended, considering the possibility of interactions.

Common Drug Conflicts

Patients should be aware of potential interactions, especially with anticoagulants or other medications that increase the risk of bleeding. It's vital to inform the prescribing doctor about any other concurrent medications to avoid complications.

User Reports & Trends

Feedback from Australian patients on various platforms illustrates a spectrum of experiences with nintedanib. Trends indicate a mix of positive outcomes and challenges, particularly with gastrointestinal issues, which are common compatibilities noted in reports. Through these patient experiences, managing side effects, including those from nintedanib, remains a primary focus for many users, revealing the necessity for further patient education and support.

Access & Purchase Options

For those seeking nintedanib, known under the brand name Ofev, accessibility is quite broad in Australia. Recognising the importance of easy access to medication for those managing chronic conditions, several avenues are available for purchase.

National chains (Chemist Warehouse, Priceline, TerryWhite)

Nintedanib can be conveniently found at major pharmacy chains including Chemist Warehouse, Priceline, and TerryWhite. These retailers are committed to adhering to regulations set by the Therapeutic Goods Administration (TGA). This compliance ensures that the medication is stored and distributed correctly, giving patients peace of mind about the quality of their treatment.

Online pharmacies and telehealth e-prescriptions

With the increasing integration of telehealth services, obtaining nintedanib has become even easier. Patients living in rural or remote areas can receive e-prescriptions through telehealth consultations. This enables them to access online pharmacies that are compliant with Australian laws, thus streamlining the process of obtaining necessary medications without the barrier of distance.

Mechanism & Pharmacology

Understanding how nintedanib functions can shed light on its efficacy in treating certain medical conditions. At its core, this medication is a tyrosine kinase inhibitor. This means it actively disrupts pathways involved in fibrogenesis and angiogenesis, crucial mechanisms contributing to the progression of fibrotic diseases such as idiopathic pulmonary fibrosis (IPF).

Simplified explanation

The simple breakdown of nintedanib's actions shows that by inhibiting certain proteins, it directly impacts the process that leads to tissue scarring and abnormal growth of blood vessels. This makes it particularly useful in managing progressive fibrosing diseases.

Clinical terms

Medical professionals might refer to nintedanib as an antifibrotic agent, a protein kinase inhibitor, or an angiogenesis inhibitor when discussing its role in disease modification. These terms encapsulate its intended influence on conditions like IPF, helping to regulate how the disease manifests and progresses within the lungs.

Indications & Off-Label Uses

Nintedanib has specific approvals from the TGA for its use, primarily targeting idiopathic pulmonary fibrosis (IPF) and systemic sclerosis-associated interstitial lung disease (SSc-ILD). This recognition marks it as a vital tool in managing the complexities of these chronic conditions.

Approved indications by TGA

The TGA has officially sanctioned nintedanib for treating both IPF and SSc-ILD, acknowledging its role in slowing disease progression and improving patients' quality of life.

Off-label uses in Australian clinical practice

In some cases, Australian healthcare practitioners may consider off-label use of nintedanib for other forms of fibrosing interstitial lung diseases or even certain malignancies. Such decisions are typically guided by ongoing research and informed clinical judgment, highlighting the dynamic nature of patient care.

Key Clinical Findings

Recent studies conducted between 2022 and 2025 within Australian populations have reinforced the effectiveness of nintedanib in managing IPF. These investigations validate its role in slowing disease progression when pitted against placebo and alternative treatment options.

Alternatives Matrix

Understanding what alternatives are available can help patients and healthcare providers make informed decisions about treatment options. A simple comparison table outlines some key medications that are PBS-listed as alternatives to nintedanib.

PBS-listed alternatives comparison table

Medication	Indication	Dose	Common Side Effects
Nintedanib	IPF, ILDs	150 mg twice daily	Diarrhea, Nausea
Pirfenidone	IPF	267 mg three times daily	Rash, Fatigue

Pros and cons checklist

Here's a quick comparison tool to help patients weigh their treatment options:

• Nintedanib: Effective in slowing disease progression, dose-dependent side effects such as gastrointestinal issues.
• Pirfenidone: Well-studied alternative with different side effect profiles, including potential skin reactions.

Common Questions

Patients often find themselves seeking advice from pharmacists when prescribed nintedanib. Concerns typically revolve around managing side effects and understanding the medication regimen.

Here are some questions commonly raised:

• What can be done to alleviate gastrointestinal side effects like nausea and diarrhoea?
• Are there specific dietary recommendations for those taking nintedanib?
• How long does nintedanib take to work?

Pharmacists play an essential role in offering practical advice, such as suggesting meals low in fat and providing hydration tips to manage these adverse effects. For those wondering about nintedanib's cost, knowing the PBS (Pharmaceutical Benefits Scheme) subsidies can also help manage expenses associated with their treatment.

Suggested Visual Content

Enhancing understanding through visual aids can significantly benefit patients being introduced to nintedanib.

Infographics illustrating:

• PBS pricing for nintedanib, detailing patient subsidies
• A pharmacy network map showcasing where nintedanib can be accessed across Australia

Such resources not only clarify the financial implications but also streamline the process of navigating the healthcare system. For patients, understanding where to obtain their medication and the financial supports available can alleviate stress during treatment. This is particularly important given the complexities surrounding nintedanib dosage and prescribing practices.

Registration & Regulation

TGA approval

Nintedanib has been officially approved by the Therapeutic Goods Administration (TGA) in Australia since the late 2010s. This approval confirms nintedanib's safety and efficacy for treating specific conditions, notably idiopathic pulmonary fibrosis (IPF).

PBS subsidy details

The PBS provides essential cost subsidies, making nintedanib financially accessible for eligible patients encountering challenges with lung diseases. Guidelines thoroughly outline patient eligibility criteria, ensuring those in need can benefit. This includes criteria based on the specific conditions being treated and the responsibilities of prescribing physicians, thereby making the treatment more manageable for patients.

Storage & Handling

Household storage in Australian climate (heat/humidity)

Considering Australia's variable climate, it's crucial to store nintedanib properly. This medication should be kept below 25°C in a cool, dry place, away from humidity. Ensuring appropriate storage protects the integrity of nintedanib capsules or tablets.

Cold-chain handling for pharmacies

For pharmacies, it is imperative to maintain recommended temperature ranges during transport and storage. Proper handling prevents degradation and ensures that patients receive effective medication. Adhering to storage guidelines is essential to uphold the quality and efficacy of nintedanib, particularly in warmer months.

Guidelines for Proper Use

Australian pharmacist counselling style

Pharmacists are encouraged to engage patients by providing clear and straightforward instructions on using nintedanib. This includes detailing potential side effects and signs indicating when to seek medical attention. Having open conversations helps ensure that patients feel supported throughout their treatment.

Patient advice from PBS and national health authorities

Patients should take their prescribed doses of nintedanib consistently and report any adverse effects or concerns to their healthcare providers. Regular follow-ups allow for monitoring treatment efficacy and prompt adjustments should side effects warrant such actions. Following professional advice is paramount to achieving the best outcomes with this medication.

City	Region	Delivery time
Sydney	NSW	5–7 days
Melbourne	VIC	5–7 days
Brisbane	QLD	5–7 days
Perth	WA	5–7 days
Adelaide	SA	5–7 days
Canberra	ACT	5–7 days
Hobart	TAS	5–9 days
Darwin	NT	5–9 days
Newcastle	NSW	5–9 days
Gold Coast	QLD	5–9 days
Cairns	QLD	5–9 days
Geelong	VIC	5–9 days
Toowoomba	QLD	5–9 days
Sunshine Coast	QLD	5–9 days